Amneal Pharmaceuticals, LLC: Drug Recall

Recall Details

Recall Number

D-0629-2024

Classification

Class III

Product Type

Drug

Recalling Firm

Amneal Pharmaceuticals, LLC

Status

Completed

Date Initiated

08/01/2024

Location

Bridgewater, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

12,624 bottles

Reason for Recall

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

Product Description

Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

Distribution Pattern

Nationwide in the USA

Other Recalls by Amneal Pharmaceuticals, LLC

• Class II: Risk 08/18/2025
  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
  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
  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
  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
  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.

View all recalls by Amneal Pharmaceuticals, LLC →