The Recall Desk

Manufacturer

Amneal Pharmaceuticals, LLC

13 recalls in our database name Amneal Pharmaceuticals, LLC as the manufacturing or recalling firm.

What the numbers show

Total
13
Critical
0
Severe
4
Most recent
2026-06-17

Of the 13 recalls from Amneal Pharmaceuticals, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (31%) 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.

1–13 of 13

  • SevereFDA (Drugs)·D-0478-2026·2026-04-08

    Magnesium sulfate pouch recalled as Class I for containing tranexamic acid

    One lot of Magnesium Sulfate in Water for Injection is being recalled after a foil pouch labeled as magnesium sulfate was found to contain an IV bag of tranexamic acid.

    Product
    MAGNESIUM SULFATE — MAGNESIUM SULFATE (MAGNESIUM SULFATE IN WATER FOR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0408-2026·2026-04-08

    Amneal tramadol tablets failed nitrosamine impurity specification at stability

    Amneal Pharmaceuticals is recalling two lots of Tramadol Hydrochloride Tablets 50 mg after a nitrosamine impurity was found out of specification at the 24-month stability interval.

    Product
    TRAMADOL HYDROCHLORIDE — TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0616-2025·2025-09-10

    Chlorpromazine 25 mg tablets recalled after micro-organism found on packaging coil

    Amneal chlorpromazine hydrochloride tablets, 25 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0618-2025·2025-09-10

    Chlorpromazine 100 mg tablets recalled over micro-organism on packaging coil

    Amneal chlorpromazine hydrochloride tablets, 100 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0619-2025·2025-09-10

    Chlorpromazine 200 mg tablets recalled over micro-organism on packaging component

    Amneal chlorpromazine hydrochloride tablets, 200 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2025·2025-09-10

    Chlorpromazine 50 mg tablets recalled over micro-organism on packaging coil

    Amneal chlorpromazine hydrochloride tablets, 50 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0615-2025·2025-09-10

    Sulfamethoxazole and trimethoprim tablets recalled over micro-organism on packaging coil

    Amneal sulfamethoxazole and trimethoprim double strength tablets are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0488-2025·2025-06-18

    Sulfamethoxazole and Trimethoprim Tablets Recalled for Microbial Contamination

    Amneal Pharmaceuticals is recalling Sulfamethoxazole and Trimethoprim Tablets (400 mg/80 mg) nationwide due to microbial contamination that may cause black spots on tablets. The contamination affects non-sterile products distributed across the USA.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0402-2025·2025-05-14

    Ropivacaine Hydrochloride Injection Recalled for Particulate Matter

    Amneal Pharmaceuticals is recalling Ropivacaine Hydrochloride Injection 0.5% due to the presence of particulate matter. The recall affects specific lots distributed nationwide.

    Product
    ROPIVACAINE HYDROCHLORIDE — ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0629-2024·2024-08-14

    Methotrexate tablets may contain wrong medication, FDA says

    Amneal Pharmaceuticals recalls Methotrexate 2.5mg tablets (Lot BB29124) distributed nationwide due to potential presence of Fludrocortisone Acetate tablets. Patients should verify their lot number with their pharmacy.

    Product
    Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0076-2018·2017-11-22

    Amneal Recalls Fosphenytoin Sodium Injection Due to Particulate Matter

    Amneal Pharmaceuticals is recalling 14,000 vials of Fosphenytoin Sodium Injection because of the presence of particulate matter.

    Product
    Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0693-2017·2017-05-10

    Amneal Recalls Rabeprazole Sodium Tablets for Failed Dissolution Specifications

    Amneal Pharmaceuticals is recalling Rabeprazole Sodium Delayed Release Tablets, 20 mg, because the product failed to meet dissolution specifications.

    Product
    Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
    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.