Amneal Pharmaceuticals of New York recalls
FDA enforcement reports naming Amneal Pharmaceuticals of New York, LLC as the recalling firm.
- Recall reports
- 26
- Class I (serious)
- 2
- Most recent report
- Sep 30, 2026
- Sep 30, 2026Exenatide Injection, USP, 250 mcg/mL, 1Drug · Amneal Pharmaceuticals of New York, LLCDefective Delivery System: Possibility of no medication in the prefilled pen.Class II
- May 8, 2024Methylergonovine Maleate Tablets, USP, 0Drug · Amneal Pharmaceuticals of New York, LLCFailed Dissolution SpecificationsClass II
- Apr 24, 2024Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL…Drug · Amneal Pharmaceuticals of New York, LLCSuperpotent Drug: Due to overfilling of drug powderClass I
- Apr 3, 2024Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactu…Drug · Amneal Pharmaceuticals of New York, LLCFailed dissolution specificationsClass II
- Feb 28, 2024Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only…Drug · Amneal Pharmaceuticals of New York, LLCFailed Impurities/Degradation Specifications: Out-of-specification test results.Class II
- Feb 14, 2024Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactu…Drug · Amneal Pharmaceuticals of New York, LLCFailed Impurities/Degradation Specifications: Out of specification for unknown impurity.Class II
- Nov 15, 2023Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amnea…Drug · Amneal Pharmaceuticals of New York, LLCFailed Dissolution SpecificationsClass II
- Jun 21, 2023Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Dist…Drug · Amneal Pharmaceuticals of New York, LLCFailed Dissolution Specifications: Out-of-specification results for dissolution (above specification)Class II
- May 31, 2023Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intr…Drug · Amneal Pharmaceuticals of New York, LLCLabeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 701…Class III
- Aug 31, 2022Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle,…Drug · Amneal Pharmaceuticals of New York, LLCFailed dissolution specifications.Class II
- Flocinolone Acetonide 0
- Flocinolone Acetonide 0
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bott…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 coun…
- amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets…
- amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Table…
- amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Table…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablet…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tabl…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amn…
- amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottle…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bott…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distribute…
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle,…
- Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed…
- Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amnea…
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