Amneal's product recalls
19 official recall notices between Nov 2023 and Oct 2026 were matched to Amneal.
Each notice concerns the specific products, sizes and lot codes it names. A recall does not mean that other Amneal products are affected, and a count of notices is not a measure of safety: one incident can produce a notice for every pack size.
Covers only notices from the U.S. Food and Drug Administration enforcement reports (openFDA), USDA Food Safety and Inspection Service recalls, UK Food Standards Agency food alerts and U.S. Consumer Product Safety Commission recalls that could be matched to Amneal: the recalling firm must be Amneal, a parent or a subsidiary, and for a brand the brand name must appear in the product description. Method.
2026 (5)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| 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. | — | Amneal Pharmaceuticals, LLC | Defective Container; packets were found to be either empty or partially full. Class II | FDA | |
| 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… | — | Amneal Pharmaceuticals of New York, LLC | Defective Delivery System: Possibility of no medication in the prefilled pen. Class II | FDA | |
| Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213,… | — | Amneal Pharmaceuticals, LLC | Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API… Class III | FDA | |
| traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India,… | — | Amneal Pharmaceuticals, LLC | Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month… Class II | FDA | |
| 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… | — | Amneal Pharmaceuticals, LLC | Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic… Class I | FDA |
2025 (7)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle,… | — | Amneal Pharmaceuticals, LLC | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a… Class II | FDA | |
| chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit,… | — | Amneal Pharmaceuticals, LLC | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a… Class II | FDA | |
| chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit,… | — | Amneal Pharmaceuticals, LLC | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a… Class II | FDA | |
| chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit,… | — | Amneal Pharmaceuticals, LLC | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a… Class II | FDA | |
| chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit,… | — | Amneal Pharmaceuticals, LLC | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a… Class II | FDA | |
| Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC:… | — | Amneal Pharmaceuticals, LLC | Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. Class I | FDA | |
| Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed… | — | Amneal Pharmaceuticals, LLC | Presence of Particulate Matter Class I | FDA |
2024 (6)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1 | — | Amneal Pharmaceuticals, LLC | Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count… Class III | FDA | |
| Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2. | — | Amneal Pharmaceuticals of New York, LLC | Failed Dissolution Specifications Class II | FDA | |
| Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300… | — | Amneal Pharmaceuticals of New York, LLC | Superpotent Drug: Due to overfilling of drug powder Class I | FDA | |
| Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed… | — | Amneal Pharmaceuticals of New York, LLC | Failed dissolution specifications Class II | FDA | |
| Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.… | — | Amneal Pharmaceuticals of New York, LLC | Failed Impurities/Degradation Specifications: Out-of-specification test results. Class II | FDA | |
| Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit,… | — | Amneal Pharmaceuticals of New York, LLC | Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. Class II | FDA |
2023 (1)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10 | — | Amneal Pharmaceuticals of New York, LLC | Failed Dissolution Specifications Class II | FDA |
Product descriptions and reasons are shortened from the regulators' own text; the linked notice is the authoritative record. See all matched recalls, or report a wrong match through the corrections page.