Recall Atlas

Amneal Pharmaceuticals recalls

8 official recalls and safety alerts involving Amneal Pharmaceuticals since 2024-08, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Amneal Pharmaceuticals or the relevant agency.

  1. 2026-10-07
  2. US
    Drugs & medicalClass II

    Amneal Pharmaceuticals, LLC recalls Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC…

    Defective Container; packets were found to be either empty or partially full.

    FDA · DrugAmneal Pharmaceuticals, LLCNationwide in the USA.Official notice →
  3. 2026-06-17
  4. US
    Drugs & medicalClass III

    Amneal Pharmaceuticals, LLC recalls Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage…

    Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

    FDA · DrugAmneal Pharmaceuticals, LLCNationwide within the USA.Official notice →
  5. 2026-04-08
  6. US
    Drugs & medicalClass I

    Amneal Pharmaceuticals, LLC recalls Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only,…

    Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.

    FDA · DrugAmneal Pharmaceuticals, LLCU.S.A. NationwideOfficial notice →
  7. US
    Drugs & medicalClass II

    Amneal Pharmaceuticals, LLC recalls traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad…

    Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).

    FDA · DrugAmneal Pharmaceuticals, LLCNationwide within the USAOfficial notice →
  8. 2025-09-10
  9. US
    Drugs & medicalClass II

    Amneal Pharmaceuticals, LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral…

    Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

    FDA · DrugAmneal Pharmaceuticals, LLCDistributed Nationwide in the USAOfficial notice →
  10. 2025-06-18
  11. US
    Drugs & medicalClass I

    Amneal Pharmaceuticals, LLC recalls Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets…

    Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

    FDA · DrugAmneal Pharmaceuticals, LLCNationwide in the USAOfficial notice →
  12. 2025-05-14
  13. US
    Drugs & medicalClass I

    Amneal Pharmaceuticals, LLC recalls Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd.,…

    Presence of Particulate Matter

    FDA · DrugAmneal Pharmaceuticals, LLCNationwide in the USOfficial notice →
  14. 2024-08-14
  15. US
    Drugs & medicalClass III

    Amneal Pharmaceuticals, LLC recalls Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC#…

    Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

    FDA · DrugAmneal Pharmaceuticals, LLCNationwide in the USAOfficial notice →