[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
- 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 (5)
- Lot #: 6133156
- 6133194
- Exp Date: 08/2026
- 6133388
- Exp Date: 10/2026.
UPCs (1)
- 0363323739119
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · FAMOTIDINE
- ModerateFamotidine tablets recalled for carton labeling error on strength
FDA (Drugs) · 2023-07-26
Same category
- ModerateTopCare Earwax Removal Kit Recalled for Subpotent Drug Content
FDA (Drugs) · 2026-07-22
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22
- ModerateCAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22