June 2025 FDA Recall Sulfamethoxazole And Trimethoprim by Amneal Pharmaceuticals, Llc
D-0488-2025 - Microbial contamination of non-sterile products
This Class I drug recall was voluntarily initiated by Amneal Pharmaceuticals, Llc on June 2, 2025 for the product Sulfamethoxazole And Trimethoprim. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0488-2025
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
06-02-2025
06-18-2025
6396 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amneal Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Batch or Lot Expiration Information
Lot# s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
