Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Daiichi SankyoLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record. See the Daiichi Sankyo group view.
As of Nov 15, 2026, FDA's public records list American Regent with 21 drug recalls. The most recent is a drug recall dated Aug 11, 2026: Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 11, 2026 | Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and SubcutaneouClass I · Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, a | Drug recalls |
| Jul 24, 2026 | Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01Class II · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformal | Drug recalls |
| Jul 24, 2026 | Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mLClass II · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformal | Drug recalls |
| Jul 24, 2026 | ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR IClass II · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformal | Drug recalls |
| Jul 24, 2026 | Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose VialClass I · Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde | Drug recalls |
| Jul 24, 2026 | ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR IClass II · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformal | Drug recalls |
| Jul 24, 2026 | Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1Class II · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformal | Drug recalls |
| Jul 24, 2026 | Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX oClass II · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformal | Drug recalls |
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
