Amneal Pharmaceuticals of New York recalls
11 official recalls and safety alerts involving Amneal Pharmaceuticals of New York since 2021-11, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Amneal Pharmaceuticals of New York or the relevant agency.
- 2026-09-30
USAmneal Pharmaceuticals of New York, LLC recalls Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use…
Defective Delivery System: Possibility of no medication in the prefilled pen.
- 2024-05-08
- US
- 2024-04-24
- US
Amneal Pharmaceuticals of New York, LLC recalls Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b)…
Superpotent Drug: Due to overfilling of drug powder
- 2024-04-03
- US
Amneal Pharmaceuticals of New York, LLC recalls Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals…
Failed dissolution specifications
FDA · DrugAmneal Pharmaceuticals of New York, LLCProduct was distributed nationwide.Official notice → - 2024-02-28
- US
Amneal Pharmaceuticals of New York, LLC recalls Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal…
Failed Impurities/Degradation Specifications: Out-of-specification test results.
- 2024-02-14
- US
Amneal Pharmaceuticals of New York, LLC recalls Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals…
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
- 2023-11-15
- US
Amneal Pharmaceuticals of New York, LLC recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC…
Failed Dissolution Specifications
FDA · DrugAmneal Pharmaceuticals of New York, LLCNationwide in the USA and Puerto RicoOfficial notice → - 2023-06-21
- US
Amneal Pharmaceuticals of New York, LLC recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal…
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
- 2023-05-31
- US
Amneal Pharmaceuticals of New York, LLC recalls Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue…
Labeling: 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…
- 2022-08-31
- US
- 2021-11-24
- US
Amneal Pharmaceuticals of New York, LLC recalls Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals…
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
FDA · DrugAmneal Pharmaceuticals of New York, LLCProduct was distributed nationwide within the United StatesOfficial notice →