The Recall Desk

Manufacturer

Amneal Pharmaceuticals, Inc.

10 recalls in our database name Amneal Pharmaceuticals, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
5
Most recent
2019-12-18

Of the 10 recalls from Amneal Pharmaceuticals, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (50%) 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.

1–10 of 10

  • SevereFDA (Drugs)·D-0615-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0612-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0614-2020·2019-12-18

    Amneal Recalls Ranitidine Syrup Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Syrup Oral Solution because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0616-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine 300 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0613-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0134-2020·2019-10-16

    Amneal Recalls Benazepril HCl Tablets Due to Foreign Tablet Presence

    Amneal Pharmaceuticals is recalling Benazepril HCl 40 mg tablets because a Promethazine HCl tablet was found in the bottle.

    Product
    BENAZEPRIL HYDROCHLORIDE — BENAZEPRIL HYDROCHLORIDE (BENAZEPRIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1516-2019·2019-07-31

    Amneal Recalls Methylergonovine Maleate Tablets Due to Foreign Tablet Presence

    Amneal Pharmaceuticals is recalling specific lots of Methylergonovine Maleate tablets because a Promethazine tablet was found in a bottle.

    Product
    Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1439-2019·2019-07-10

    Amneal Recalls Subpotent Esterified Estrogens and Methyltestosterone Tablets

    Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone Tablets because they failed potency testing.

    Product
    Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1438-2019·2019-07-10

    Amneal Recalls Subpotent Esterified Estrogens and Methyltestosterone Tablets

    Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone tablets due to out-of-specification assay results.

    Product
    Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Amneal Pharmaceuticals, Inc.

American publicly traded generics and specialty pharmaceutical company

Country
United States

Official website

Source: Wikidata (Q16996714), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.