Filing Flows › Amneal Pharmaceuticals (AMRX) › Recalls, complaints & regulation
Amneal Pharmaceuticals (AMRX): recalls, EPA violations and clinical trials
Amneal Pharmaceuticals (AMRX) beyond its filings: 5 recalls in the last 12 months (24 in five years, 4 Class I); 1 EPA-regulated facility in violation, no penalties in five years; 2 active clinical trials.
Latest recalls
- 2026-10-07 · FDA drug · Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.
- 2026-09-30 · FDA drug · Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuti
- 2026-06-17 · FDA drug · Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, IND
- 2026-04-08 · FDA drug · traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed
- 2026-04-08 · FDA drug · Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharm
- 2025-09-10 · FDA drug · chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedab
- 2025-09-10 · FDA drug · chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmeda
- 2025-09-10 · FDA drug · chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedab
EPA facilities in violation
| Facility (as registered) | City | Status | Penalties |
|---|---|---|---|
| AMNEAL PHARMACEUTICALS | Piscataway, NJ | Significant Violation | — |
Facilities in the EPA's ECHO register whose registered name matches the company's; a facility can belong to another business of the same name.
Amneal Pharmaceuticals' latest quarter
Amneal Pharmaceuticals, Q3 2026: revenue $863M (+10% year over year), operating margin 11.1%, net earnings $12.3M, operating cash flow $98.3M. The chart follows the revenue to costs, profit and cash.
Questions
Has Amneal Pharmaceuticals had any recalls?
24 recalls on file over five years from the FDA, CPSC and NHTSA; 5 in the last 12 months.
Has Amneal Pharmaceuticals been fined by the EPA?
The 12 EPA-regulated facilities on file under its name drew no penalties in five years; 1 is in violation now.
How many clinical trials does Amneal Pharmaceuticals have?
2 active studies on ClinicalTrials.gov, 2 in phase 3.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.