The Recall Desk
HighFDA (Drugs)·D-0182-2026·Announced 2025-12-03

[pending] FAMOTIDINE (FAMOTIDINE)

Pending LLM rewrite. Source: FDA_DRUG D-0182-2026.

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

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

The recalled product

Product
FAMOTIDINE (FAMOTIDINE)
Brand
FAMOTIDINE
Manufacturer
Fresenius Kabi USA, LLC

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 (5)

  • Lot #: 6133156
  • 6133194
  • Exp Date: 08/2026
  • 6133388
  • Exp Date: 10/2026.

UPCs (1)

  • 0363323739119

Distribution

Distributed nationwide across the United States.

Same brand · FAMOTIDINE