Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 6 companies' records, each linked to the record.
As of Nov 13, 2026, FDA's public records list Endo and its 6 subsidiaries with 90 510(k) clearances, 42 drug applications, 17 drug recalls, 6 device recalls, 1 complete response letter and 1 warning letter. The most recent is a warning letter dated Apr 15, 2026: Warning letter: Aseptic processing, Sterility assurance, Environmental monitoring.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Endo and its 6 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Apr 15, 2026 | Warning letter: Aseptic processing, Sterility assurance, Environmental monitoringCDER | Warning letters |
| Nov 10, 2022 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. MClass II · Failed Impurities/Degradation Specifications | Drug recalls |
| Nov 30, 2018 | Complete response letter, NDA 209511Approved | Complete response letters |
| Oct 15, 2014 | AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVaClass II · During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the | Device recalls |
| Oct 15, 2014 | AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195,Class II · During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the | Device recalls |
| Oct 10, 2014 | AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 AClass II · AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Ba | Device recalls |
| Jun 20, 2014 | SUREFLEX LITHOTRIPSY LASER FIBERSK140679 · GEX | 510(k) clearances |
| May 1, 2014 | COLLACARE DENTALK133290 · KGN | 510(k) clearances |
| Dec 5, 2013 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMSK131229 · OTN | 510(k) clearances |
| Nov 20, 2013 | RETROARC RETROPUBIC SLING SYSTEMK132655 · OTN | 510(k) clearances |
| Mar 1, 2013 | AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistClass II · American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control | Device recalls |
| Mar 1, 2013 | AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistaClass II · American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control | Device recalls |
| Oct 19, 2012 | AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMSClass II · American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdV | Device recalls |
| Oct 16, 2012 | AMS LARGE PORE POLYPROPHLENE MESHK121805 · OTO | 510(k) clearances |
| Sep 7, 2012 | MINIARC PRO SINGLE-INCISION SLING SYSTEMK121641 · PAH | 510(k) clearances |
| Jul 20, 2012 | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATIONK121612 · OTP | 510(k) clearances |
| Jun 21, 2012 | PROCOLLK120339 · KGN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
