Home / Recalls / Amneal Pharmaceuticals, LLC / D-0629-2024

D-0629-2024 Class III

Recalled by Amneal Pharmaceuticals, LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
August 14, 2024
Initiation Date
August 1, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,624 bottles

Product Description

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

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot # BB29124, Exp. 02/28/2026

Other recalls by Amneal Pharmaceuticals, LLC

  • D-0619-2025 Class II — chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Ma (August 18, 2025)
  • D-0616-2025 Class II — chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Ma (August 18, 2025)
  • D-0615-2025 Class II — Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx (August 18, 2025)
  • D-0618-2025 Class II — chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, M (August 18, 2025)
  • D-0617-2025 Class II — chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Man (August 18, 2025)
  • D-0488-2025 Class I — Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Ta (June 2, 2025)
  • D-0402-2025 Class I — Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manu (April 17, 2025)
  • D-0614-2020 Class II — Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90. (November 22, 2019)
  • D-0616-2020 Class II — Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02. (November 22, 2019)
  • D-0615-2020 Class II — Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10. (November 22, 2019)