Amneal Pharmaceuticals, LLC

8 FDA enforcement actions

8 Total Recalls

2 Class I

5 Class II

1 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 08/18/2025 drug

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.
Class II: Risk 08/18/2025 drug

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.
Class II: Risk 08/18/2025 drug

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.
Class II: Risk 08/18/2025 drug

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.
Class II: Risk 08/18/2025 drug

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.
Class I: Dangerous 06/02/2025 drug

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Class I: Dangerous 04/17/2025 drug

Presence of Particulate Matter
Class III: Low Risk 08/01/2024 drug

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.