The Recall Desk
HighFDA (Drugs)·D-0615-2025·Announced 2025-09-10

[pending] SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)

Pending LLM rewrite. Source: FDA_DRUG D-0615-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Brand
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Manufacturer
Amneal Pharmaceuticals, LLC
Category
Drug — Drugs

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot a) AM240173
  • Exp Date 01/31/2027
  • AM240680
  • Exp Date 05/31/2027
  • AM 240921
  • Exp Date 06/30/2027
  • AM241191
  • Exp Date 08/31/2027. Lot b) AM240176
  • AM240177
  • AM240301
  • AM240300
  • Exp Date 02/28/2027
  • AM240676
  • AM240677
  • Exp Date 04/30/2027
  • AM240678
  • AM240679
  • Exp Date 05/30/2027. AM240922
  • AM240923
  • AM240924

UPCs (2)

  • 0365168211102
  • 0365162272109

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · SULFAMETHOXAZOLE AND TRIMETHOPRIM

Same category