Arca

FDA this week

Oct 12 to Oct 18, 2026

What FDA published for drug, device and biologics teams: 5 warning letters, 9 OAI inspections, 35 recalls, 2 new guidances, 4 Federal Register documents, 44 drug shortage updates.

Medline bed fires and Draeger neonatal circuit cracks

  • Medline expanded its bed fire recall to 771,127 units after 12 injuries and one death[1][2].
  • Draeger removed VentStar Resus Neo hoses for cracks that can block infant ventilation[3].
  • CBER finalized two blood donor eligibility compliance policies in October 2026[4].

Medline Industries, LP expanded its November 2025 homecare bed correction in August 2026 to add bed and pendant codes, with FDA listing the action as Class I and the cause as device design[1][5]. The reason is a fire hazard from the hand control pendant and wiring that may overheat and lead to smoking, sparking, melting, burning or fire, covering 771,127 units distributed nationwide and in Bermuda, Canada and Panama[1]. FDA reports 12 injuries and one death linked to pendant overheating and two injuries and one death linked to entrapment when non-Medline accessories are used, noting patients at home face increased risk from delayed detection[2].

Draeger removed VentStar Resus Neo model MP00310, a disposable breathing circuit that conveys gas to infants up to 22 lbs, after users found obvious cracks in the hose before use[3]. A cracked hose may fall off or leak and cause restricted ventilation or delayed therapy that could lead to desaturation, hypoxia or patient death, with no serious injuries or deaths reported as of September 3[3]. FDA issued an Early Alert on September 3, 2026 and classified the action as a Class I recall on October 2, 2026[3].

The Center for Biologics Evaluation and Research finalized its compliance policy on donation suitability, donor eligibility and Source Plasma quarantine hold for blood establishments that collect blood and blood components[6]. The policy covers donation suitability under 21 CFR 630.30, donor eligibility under 21 CFR 630.10(c)(2) and quarantine hold under 21 CFR 640.69(f), finalizing the May 2022 draft and superseding the April 2020 COVID procedures guidance[6]. A second final compliance policy addresses blood pressure and pulse donor eligibility requirements for the same establishments collecting for transfusion or further manufacturing use[7].

Both Class I device actions depend on users following updated handling, with Medline limiting beds to Medline rails and accessories and Draeger directing inspection and discard of cracked or detached hoses[2][3]. FDA also announced availability of the final questions and answers guidance on postapproval manufacturing changes to biosimilar and interchangeable biosimilar products, published October 13, 2026 to finalize the July 2024 draft[8].

Sources

Written with Arca Research, which cites every claim to its source.

Warning letters 5

Inspections classified Official Action Indicated 9

Recalls 35

Draeger, Inc.Class I

VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.

Class I · Device · Potential cracks in the hose, which could lead to leakage or the hose falling off.

Full record

Medline Industries, LPClass I

Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE (and 1 more product)

Class I · Device · Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting…

Full record

Ajanta Pharma USA Inc

Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC…

Class II · Drug · Failed Dissolution Specifications: below specification

Full record

Alere San Diego, Inc.

Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part… (and 3 more products)

Class II · Device · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Full record

American Contract Systems Inc

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No… (and 2 more products)

Class II · Device · Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated…

Full record

American Nitrile Operations Llc

Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product… (and 2 more products)

Class II · Device · Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or…

Full record

Amneal Pharmaceuticals, LLC

Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC…

Class II · Drug · Defective Container; packets were found to be either empty or partially full.

Full record

Apotex Corp.

Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9…

Class II · Drug · Failed dissolution specifications.

Full record

ASP Global, LLC.

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 Software… (and 63 more products)

Class II · Device · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Full record

Aurolab Trust

FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109…

Class II · Drug · Lack of Assurance of Sterility

Full record

Bard Peripheral Vascular Inc

EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with…

Class II · Device · Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which…

Full record

Beckman Coulter Mishima K.K.

Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 /…

Class II · Device · Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software…

Full record

Cardinal Health 200, LLC

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT… (and 3 more products)

Class II · Device · The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can…

Full record

Custom Interventional Pain Management, LLC

Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog…

Class II · Device · Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.

Full record

Heraeus Medical GmbH (Dental Division)

PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone… (and 3 more products)

Class II · Device · Potential for monomer liquid leakage.

Full record

Illumina, Inc.

NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130

Class II · Device · Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security…

Full record

Karl Storz Endoscopy

HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for…

Class II · Device · Due to incorrect inside packaging label for eyepiece.

Full record

Merit Medical Systems, Inc.

Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile…

Class II · Device · Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could…

Full record

Micro Therapeutics, Inc.

Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device…

Class II · Device · Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.

Full record

NOXBOX LTD

NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.

Class II · Device · Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.

Full record

Olympus Corporation of the Americas

Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A. (and 1 more product)

Class II · Device · There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

Full record

Olympus Corporation of the Americas

Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE Hub System

Class II · Device · While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.

Full record

Par Health USA, LLC

Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC…

Class II · Drug · Crystallization

Full record

Penumbra Inc.

Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number…

Class II · Device · Due to manufacturing issues reperfusion catheters may fracture.

Full record

Percussionaire Corporation

Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC (and 6 more products)

Class II · Device · Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile…

Full record

Philips North America

Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions… (and 11 more products)

Class II · Device · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is…

Full record

Philips North America Llc

Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333

Class II · Device · The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving…

Full record

Shanghai United Imaging Healthcare Co., Ltd.

Computed Tomography X-ray System, Model: uCT 530 with software (and 11 more products)

Class II · Device · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents…

Full record

Siemens Healthcare Diagnostics, Inc.

Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;

Class II · Device · The potential for falsely elevated results.

Full record

SPECTRUM MEDICAL SRL

Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software… (and 1 more product)

Class II · Device · Due to blood-to-glycol leak in the heat exchanger.

Full record

SV Labs Toronto Corporation

Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles (NDC… (and 1 more product)

Class II · Drug · Microbial contamination of topical product.

Full record

Tandem Diabetes Care, Inc.

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13…

Class II · Device · A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P)…

Full record

TerSera Therapeutics LLC

Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC…

Class II · Drug · Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.

Full record

Volcano Corp

Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA

Class II · Device · Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

Full record

Wright Medical Technology, Inc.

CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System

Class II · Device · Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid…

Full record

New guidance documents 2

Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements: Guidance for Industry

Final · CBER

Read at FDA

Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for Industry

Final · CBER

Read at FDA

Federal Register: rules, proposed rules and notices 4

Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0

Notice

Read in the Federal Register

Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version…

Notice

Read in the Federal Register

Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments

Notice · comments close 2026-12-11

Read in the Federal Register

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability

Notice

Read in the Federal Register

Current drug shortages updated this week 44

Avet Pharmaceuticals, Inc.

Furosemide Injection · Injection · Furosemide, Injection, 10 mg/1 mL (NDC 23155-473-44)

Current · Reverified · updated 2026-10-15 · NDC 23155-473-44 · reason: Other · availability: Unavailable

Check current status at FDA

Cumberland Pharmaceuticals Inc.

Conivaptan Hydrochloride Injection · Injection · Vaprisol Dextrose In Plastic Container, Injection, 20 mg/100 mL (NDC 66220-160-10)

Current · Reverified · updated 2026-10-15 · NDC 66220-160-10 · reason: Delay in shipping of the drug · availability: Unavailable

Check current status at FDA

EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.)

Riluzole Oral Suspension · Oral Suspension · Tiglutik, Oral Suspension, 50 mg/10 mL (NDC 70726-0303-1)

Current · Reverified · updated 2026-10-15 · NDC 70726-0303-1 · reason: Requirements related to complying with good manufacturing practices · availability: Unavailable

Check current status at FDA

Elite Laboratories, Inc.

Lisdexamfetamine Dimesylate Capsule · Capsule · Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 64850-550-01) (+6 related packages)

Current · Reverified · updated 2026-10-15 · NDC 64850-550-01 · reason: Shortage of an active ingredient · availability: Limited Availability · 7 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Lidocaine Hydrochloride Injection · Injection · Xylocaine, Injection, 20 mg/1 mL (NDC 63323-496-97) (+7 related packages)

Current · Reverified · updated 2026-10-15 · NDC 63323-496-97 · reason: Demand increase for the drug · availability: Unavailable · 8 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Bupivacaine Hydrochloride Injection · Injection · Sensorcaine, Injection, 5 mg/1 mL (NDC 63323-466-31)

Current · Reverified · updated 2026-10-15 · NDC 63323-466-31 · reason: Delay in shipping of the drug · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Dexmedetomidine Hydrochloride Injection · Injection · Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-00) (+1 related packages)

Current · Reverified · updated 2026-10-15 · NDC 63323-671-00 · reason: Delay in shipping of the drug · availability: Unavailable · 2 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Ropivacaine Hydrochloride Injection · Injection · Naropin, Injection, 2 mg/1 mL (NDC 63323-285-61) (+2 related packages)

Current · Reverified · updated 2026-10-15 · NDC 63323-285-61 · reason: Other · availability: Unavailable · 3 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Epinephrine Bitartrate, Lidocaine Hydrochloride Injection · Injection · Xylocaine, Injection, .005 mg/1 mL; 5 mg/1 mL (NDC 63323-481-57) (+1 related packages)

Current · Reverified · updated 2026-10-15 · NDC 63323-481-57 · reason: Demand increase for the drug · availability: Unavailable · 2 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection · Injection · Sensorcaine, Injection, 5 mg/1 mL; .005 mg/1 mL (NDC 63323-463-57) (+1 related packages)

Current · Reverified · updated 2026-10-15 · NDC 63323-463-57 · reason: Demand increase for the drug · availability: Unavailable · 2 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Morphine Sulfate Injection · Injection · Morphine Sulfate, Injection, 4 mg/1 mL (NDC 63323-454-01)

Current · Reverified · updated 2026-10-15 · NDC 63323-454-01 · reason: Other · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Dexamethasone Sodium Phosphate Injection · Injection · Dexamethasone Sodium Phosphate, Injection, 10 mg/1 mL (NDC 76045-0212-10) (+2 related packages)

Current · Revised · updated 2026-10-15 · NDC 76045-0212-10 · reason: Demand increase for the drug · availability: Unavailable · 3 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Hydromorphone Hydrochloride Injection · Injection · Dilaudid, Injection, .2 mg/1 mL (NDC 76045-121-11) (+3 related packages)

Current · Reverified · updated 2026-10-15 · NDC 76045-121-11 · reason: Other · availability: Unavailable · 4 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Ketorolac Tromethamine Injection · Injection · Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 76045-104-10) (+2 related packages)

Current · Reverified · updated 2026-10-15 · NDC 76045-104-10 · reason: Other · availability: Unavailable · 3 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Atropine Sulfate Injection · Injection · Atropine Sulfate, Injection, .4 mg/1 mL (NDC 63323-580-20)

Current · Reverified · updated 2026-10-15 · NDC 63323-580-20 · reason: Other · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Ropivacaine Hydrochloride Injection · Injection · Naropin, Injection, 2 mg/1 mL (NDC 63323-285-10) (+1 related packages)

Current · Reverified · updated 2026-10-15 · NDC 63323-285-10 · reason: Demand increase for the drug · availability: Unavailable · 2 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Midazolam Hydrochloride Injection · Injection · Midazolam Hydrochloride Preservative Free, Injection, 2 mg/2 mL (NDC 76045-211-20) (+1 related packages)

Current · Reverified · updated 2026-10-15 · NDC 76045-211-20 · reason: Demand increase for the drug · availability: Unavailable · 2 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Ifosfamide Injection · Injection · Ifosfamide, Injection, 1 g/1 (NDC 63323-142-10)

Current · Reverified · updated 2026-10-15 · NDC 63323-142-10 · reason: Demand increase for the drug · availability: Limited Availability

Check current status at FDA

Fresenius Kabi USA, LLC

Rifampin Injection · Injection · Rifampin, Injection, 600 mg (NDC 63323-351-20)

Current · Reverified · updated 2026-10-15 · NDC 63323-351-20 · reason: Other · availability: Limited Availability

Check current status at FDA

Fresenius Kabi USA, LLC

Rocuronium Bromide Injection · Injection · Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 65219-065-05) (+1 related packages)

Current · Reverified · updated 2026-10-15 · NDC 65219-065-05 · reason: Delay in shipping of the drug · availability: Unavailable · 2 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Bupivacaine Hydrochloride Injection · Injection · Sensorcaine, Injection, 2.5 mg/1 mL (NDC 63323-464-31)

Current · Reverified · updated 2026-10-15 · NDC 63323-464-31 · reason: Demand increase for the drug · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Valproate Sodium Injection · Injection · Valproate Sodium, Injection, 100 mg/1 mL (NDC 63323-494-05)

Current · Reverified · updated 2026-10-15 · NDC 63323-494-05 · reason: Demand increase for the drug · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Midazolam Hydrochloride Injection · Injection · Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-411-10)

Current · Reverified · updated 2026-10-15 · NDC 63323-411-10 · reason: Delay in shipping of the drug · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Ropivacaine Hydrochloride Injection · Injection · Naropin, Injection, 10 mg/1 mL (NDC 63323-288-10) (+3 related packages)

Current · Reverified · updated 2026-10-15 · NDC 63323-288-10 · reason: Delay in shipping of the drug · availability: Unavailable · 4 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Propranolol Hydrochloride Injection · Injection · Propranolol Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-604-01)

Current · Reverified · updated 2026-10-15 · NDC 63323-604-01 · reason: Delay in shipping of the drug · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Sodium Acetate Injection · Injection · Sodium Acetate, Injection, 4 meq/100 mL (NDC 63323-032-00)

Current · Revised · updated 2026-10-15 · NDC 63323-032-00 · reason: Other · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection · Injection · Sensorcaine, Injection, 5 mg/1 mL; .005 mg/1 mL (NDC 63323-462-31)

Current · Reverified · updated 2026-10-15 · NDC 63323-462-31 · reason: Delay in shipping of the drug · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Epinephrine Bitartrate, Lidocaine Hydrochloride Injection · Injection · Xylocaine, Injection, .005 mg/1 mL; 20 mg/1 mL (NDC 63323-489-27)

Current · Reverified · updated 2026-10-15 · NDC 63323-489-27 · reason: Other · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Dexmedetomidine Hydrochloride Injection · Injection · Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 63323-421-02)

Current · Reverified · updated 2026-10-15 · NDC 63323-421-02 · reason: Demand increase for the drug · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Sterile Water Injection · Injection · Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-10)

Current · Reverified · updated 2026-10-15 · NDC 63323-185-10 · reason: Demand increase for the drug · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Dexmedetomidine Hydrochloride Injection · Injection · Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-20)

Current · Reverified · updated 2026-10-15 · NDC 63323-671-20 · reason: Other · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Ketorolac Tromethamine Injection · Injection · Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 63323-162-01) (+1 related packages)

Current · Reverified · updated 2026-10-15 · NDC 63323-162-01 · reason: Delay in shipping of the drug · availability: Unavailable · 2 related packages grouped

Check current status at FDA

Fresenius Kabi USA, LLC

Azacitidine Injection · Injection · Azacitidine, Injection, 100 mg/30 mL (NDC 63323-771-39)

Current · Reverified · updated 2026-10-15 · NDC 63323-771-39 · reason: Discontinuation of the manufacture of the drug · availability: Unavailable

Check current status at FDA

Fresenius Kabi USA, LLC

Morphine Sulfate Injection · Injection · Morphine Sulfate, Injection, 5 mg/1 mL (NDC 63323-455-01)

Current · Reverified · updated 2026-10-15 · NDC 63323-455-01 · reason: Demand increase for the drug · availability: Unavailable

Check current status at FDA

Lannett Company, Inc.

Methylphenidate Hydrochloride Tablet, Extended Release · Tablet · Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 62175-312-37) (+1 related packages)

Current · Reverified · updated 2026-10-15 · NDC 62175-312-37 · reason: Other · availability: Unavailable · 2 related packages grouped

Check current status at FDA

Milla Pharmaceuticals

Sodium Acetate Injection · Injection · Sodium Acetate, Injection, 400 mEq/100mL (4 mEq/mL) (NDC 71357-009-10)

Current · Reverified · updated 2026-10-15 · NDC 71357-009-10 · reason: Other · availability: Limited Availability

Check current status at FDA

Oryza Pharmaceuticals Inc.

Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet · Tablet · Amphetamine Aspartate Monohydrate, Amphetamine Sulfate… (+4 related packages)

Current · Reverified · updated 2026-10-15 · NDC 72516-012-01 · reason: Shortage of an active ingredient · availability: Unavailable · 5 related packages grouped

Check current status at FDA

Par Health, USA LLC

Methylprednisolone Acetate Injection · Injection · Methylprednisolone Acetate, Injection, 80 mg/1 mL (NDC 42023-240-01)

Current · Reverified · updated 2026-10-15 · NDC 42023-240-01 · reason: Other · availability: Unavailable

Check current status at FDA

Par Health, USA LLC

Dexmedetomidine Hydrochloride Injection · Injection · Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20) (+2 related packages)

Current · Reverified · updated 2026-10-15 · NDC 42023-186-20 · reason: Other · availability: Unavailable · 3 related packages grouped

Check current status at FDA

Teva Pharmaceuticals USA, Inc.

Carboplatin Injection · Injection · Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4239-01)

Current · Reverified · updated 2026-10-15 · NDC 0703-4239-01 · reason: Other · availability: Limited Availability

Check current status at FDA

Teva Pharmaceuticals USA, Inc.

Methotrexate Sodium Injection · Injection · Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3678-01) (+1 related packages)

Current · Reverified · updated 2026-10-15 · NDC 0703-3678-01 · reason: Other · availability: Limited Availability · 2 related packages grouped

Check current status at FDA

Teva Pharmaceuticals USA, Inc.

Methylphenidate Hydrochloride Tablet, Extended Release · Tablet · Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 62037-726-01)

Current · Reverified · updated 2026-10-15 · NDC 62037-726-01 · reason: Other · availability: Limited Availability

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Teva Pharmaceuticals USA, Inc.

Streptozocin Powder, For Solution · Powder, For Solution · Zanosar, Powder, For Solution, 100 mg/1 mL (NDC 0703-4636-01)

Current · Reverified · updated 2026-10-15 · NDC 0703-4636-01 · reason: Other · availability: Unavailable

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Teva Pharmaceuticals USA, Inc.

Hydroxocobalamin Injection · Injection · Hydroxocobalamin, Injection, 1000 MCG/ML, 30 ML Multi-Dose Vial (NDC 0591-2888-30)

Current · Reverified · updated 2026-10-15 · NDC 0591-2888-30 · reason: Other · availability: Unavailable

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