PlainRecalls

Amneal Pharmaceuticals of New York, LLC

26 recalls on record · Latest: May 8, 2024

Amneal Pharmaceuticals of New York, LLC Recall Insight

Amneal Pharmaceuticals of New York, LLC appears on 26 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.031% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 8, 2024, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 26 entries, severity tagging shows 2 critical, 23 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 26 of 26 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Drug (26). The date window on this page runs from Nov 13, 2013 to May 8, 2024.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Drug Moderate May 8, 2024

Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 692…

FDA Drug Critical Apr 24, 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…

FDA Drug Moderate Apr 3, 2024

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Dis…

FDA Drug Moderate Feb 28, 2024

Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 0…

FDA Drug Moderate Feb 14, 2024

Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Uni…

FDA Drug Moderate Nov 15, 2023

Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10

FDA Drug Moderate Jun 21, 2023

Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807…

FDA Drug Low May 31, 2023

Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous …

FDA Drug Moderate Aug 31, 2022

Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distr…

FDA Drug Moderate Nov 24, 2021

Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65…

FDA Drug Moderate Nov 24, 2021

Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 6…

FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd.…

FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewa…

FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgew…

FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC …

FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178…

FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, N…

FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedab…

FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahm…

FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewate…

FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. …

FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewa…

FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. …

FDA Drug Moderate May 6, 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 60846-3…

FDA Drug Critical Dec 27, 2017

Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal…

FDA Drug Moderate Nov 13, 2013

Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal P…

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds