The Recall Desk

Manufacturer

Amneal Pharmaceuticals of New York, LLC.

26 recalls in our database name Amneal Pharmaceuticals of New York, LLC. as the manufacturing or recalling firm.

What the numbers show

Total
26
Critical
0
Severe
15
Most recent
2024-05-08

Of the 26 recalls from Amneal Pharmaceuticals of New York, LLC. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (58%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 26

  • HighFDA (Drugs)·D-0477-2024·2024-05-08

    Methylergonovine Maleate tablets recalled for failed dissolution specifications

    Amneal Pharmaceuticals recalls Methylergonovine Maleate 0.2mg tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially reducing medication effectiveness.

    Product
    METHYLERGONOVINE MALEATE — METHYLERGONOVINE MALEATE (METHYLERGONOVINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0442-2024·2024-04-24

    Vancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling

    Amneal Pharmaceuticals is recalling Vancomycin Hydrochloride Oral Solution nationwide due to manufacturing overfilling causing superpotency with higher-than-labeled concentration. The FDA classified this as Class I.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0426-2024·2024-04-03

    Divalproex Sodium 250 mg tablets recalled for failed dissolution specifications

    Amneal Pharmaceuticals is recalling Divalproex Sodium Extended-release Tablets 250 mg nationwide due to failed dissolution specifications. The tablets may not dissolve properly, affecting medication effectiveness.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0327-2024·2024-02-28

    FDA Recalls Oseltamivir Phosphate Oral Suspension for Out-of-Specification Impurities

    Amneal Pharmaceuticals is recalling 46,037 bottles of Oseltamivir Phosphate Oral Suspension due to failed quality test results showing impurities and degradation. The FDA classified this as a Class II recall affecting nationwide distribution.

    Product
    OSELTAMIVIR PHOSPHATE — OSELTAMIVIR PHOSPHATE (OSELTAMIVIR PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0319-2024·2024-02-14

    Amneal Phenoxybenzamine Hydrochloride Capsules 10mg Recalled Due to Unknown Impurity

    Amneal Pharmaceuticals is recalling Phenoxybenzamine Hydrochloride Capsules, 10mg, due to an unknown impurity. The recall affects 858 bottles distributed nationwide.

    Product
    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, Bridgewater, NJ 08807, NDC 60219-1502-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0090-2024·2023-11-15

    Prescription Drug Recalled Due to Failed Dissolution Specifications

    Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules nationwide (lot HM03221A) due to failed dissolution specifications, which means the tablets may not dissolve as intended.

    Product
    EXTENDED PHENYTOIN SODIUM — EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0876-2023·2023-06-21

    Prescription Drug Recall: Extended Phenytoin Sodium Dissolution Failure

    Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules (Lot HL00721A, Exp. 12/2023) due to failed dissolution specifications. The extended-release mechanism did not function properly, which could affect medication absorption.

    Product
    EXTENDED PHENYTOIN SODIUM — EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Drugs)·D-0756-2023·2023-05-31

    Methylprednisolone Acetate Injectable Suspension recalled for NDC carton labeling error

    Amneal Pharmaceuticals recalls Methylprednisolone Acetate Injectable Suspension due to incorrect NDC number on product cartons. The typographical error appears on secondary packaging only; the medication vial itself is unaffected.

    Product
    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. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Phar
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1362-2022·2022-08-31

    Divalproex Sodium Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Amneal Pharmaceuticals is recalling 4,309 bottles of Divalproex Sodium Extended-Release Tablets (250 mg) due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting medication effectiveness.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0233-2022·2021-11-24

    Flocinolone Acetonide 0.01% Topical Oil Recalled for Subpotency

    Amneal Pharmaceuticals is recalling Flocinolone Acetonide 0.01% Topical Oil due to an out-of-specification assay result indicating the drug is subpotent and may not deliver the intended therapeutic dose.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0234-2022·2021-11-24

    Flocinolone Acetonide 0.01% Topical Oil Recalled for Subpotent Drug

    Amneal Pharmaceuticals is recalling Flocinolone Acetonide 0.01% Topical Oil because testing found out-of-specification assay results, meaning the drug may contain less active ingredient than labeled.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1347-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1354-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1352-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1343-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling 192 bottles of Metformin Hydrochloride Extended-Release Tablets, 500 mg, due to N-Nitrosodimethylamine (NDMA) impurity levels above acceptable intake limits.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1345-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1393-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1348-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1349-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1353-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.

    Product
    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 Bridgewater, NJ 08807 NDC 65162-0178-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1344-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1351-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets, 500 mg, because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1350-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0120-2018·2017-12-27

    Amneal Recalls Lorazepam Oral Concentrate Due to Defective Dropper Markings

    Amneal Pharmaceuticals is recalling Lorazepam Oral Concentrate because dropper measurement markings may be reversed, shifted, or missing, which could lead to dosing errors.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide