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Amneal Pharmaceuticals of New York, LLC FDA Recalls
12 recalls on file across drugs, 1 of them Class I and 1 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use OClass IIAug 28, 2026Defective Delivery System: Possibility of no medication in t |
| Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, BriClass IIMar 25, 2024Failed Dissolution Specifications |
| Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 15Class IMar 21, 2024Superpotent Drug: Due to overfilling of drug powder |
| Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal PharmaceuClass IIFeb 13, 2024Failed Impurities/Degradation Specifications: Out-of-specifi |
| Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals PvClass IIJan 15, 2024Failed Impurities/Degradation Specifications: Out of specifi |
| Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals PvClass IIDec 26, 2023Failed dissolution specifications |
| Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC BridgewaterClass IIOct 27, 2023Failed Dissolution Specifications |
| Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal PharmaceuticalClass IIMay 30, 2023Failed Dissolution Specifications: Out-of-specification resu |
| Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue InjectiClass IIIMay 8, 2023Labeling: Not Elsewhere Classified; A typographical error wa |
| Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Class IIJul 27, 2022Failed dissolution specifications. |
| Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Class IINov 4, 2021Subpotent Drug: Out-of-specification assay result was obtain |
| Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal PharmaceuticalsClass IINov 4, 2021Subpotent Drug: Out-of-specification assay result was obtain |