Brookhaven, NY, United States
Amneal Pharmaceuticals of New York, LLC recalls
13 recalls recorded since 2018, most recently on 28 August 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls13
Ongoing (FDA)2
Terminated or completed11
Class I (FDA)1
Ongoing Class II Drugs
- Recall started
- 28 August 2026
- Reason
- Defective Delivery System: Possibility of no medication in the prefilled pen.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0868-2026
- 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 Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amn
Completed Class II Drugs
- Recall started
- 25 March 2024
- Reason
- Failed Dissolution Specifications
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0477-2024
- Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Terminated Class I Drugs
- Recall started
- 21 March 2024
- Terminated
- 21 July 2025
- Reason
- Superpotent Drug: Due to overfilling of drug powder
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0442-2024
- 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 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal
Terminated Class II Drugs
- Recall started
- 13 February 2024
- Terminated
- 14 February 2025
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification test results.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0327-2024
- Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
Terminated Class II Drugs
- Recall started
- 15 January 2024
- Terminated
- 31 January 2025
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0319-2024
- Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC,
Terminated Class II Drugs
- Recall started
- 26 December 2023
- Terminated
- 16 August 2024
- Reason
- Failed dissolution specifications
- Distribution
- Product was distributed nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0426-2024
- Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 651
Terminated Class II Drugs
- Recall started
- 27 October 2023
- Terminated
- 6 August 2025
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0090-2024
- Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Terminated Class II Drugs
- Recall started
- 30 May 2023
- Terminated
- 10 June 2025
- Reason
- Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
- Distribution
- LA, PA and OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0876-2023
- Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Terminated Class III Drugs
- Recall started
- 8 May 2023
- Terminated
- 21 March 2024
- Reason
- 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 70121-1574-1.
- Distribution
- Nationwide in the USA and PR
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0756-2023
- Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt
Terminated Class II Drugs
- Recall started
- 27 July 2022
- Terminated
- 17 August 2023
- Reason
- Failed dissolution specifications.
- Distribution
- USA nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1362-2022
- Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Terminated Class II Drugs
- Recall started
- 4 November 2021
- Terminated
- 9 June 2022
- Reason
- Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
- Distribution
- Product was distributed nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0233-2022, D-0234-2022
- Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86
- Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86
Ongoing Class II Drugs
- Recall started
- 29 May 2020
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1349-2020, D-1348-2020, D-1351-2020, D-1354-2020, D-1350-2020, D-1352-2020, D-1353-2020, D-1344-2020, D-1393-2020, D-1347-2020, D-1343-2020, D-1345-2020
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Br
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01
- amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewate
- amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridge
- and 4 more product lines
Terminated Class II Drugs
- Recall started
- 15 April 2020
- Terminated
- 8 September 2021
- Reason
- CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1253-2020
- Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.