Baxter Recalls Famotidine Injection Due to Manufacturing Deviations
Baxter Healthcare is voluntarily recalling specific lots of Famotidine Injection due to CGMP deviations. The product was distributed in the US, Puerto Rico, and Chile.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe).
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling specific lots of Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container. The recall is initiated due to Current Good Manufacturing Practice (CGMP) deviations. The affected product is identified by NDC 0338-5197-41 and includes Lot # NC188586 (Expiration Date: 02/28/2027) and Lot # NC188913 (Expiration Date: 3/9/2027).
The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The affected product was distributed nationwide in the United States, as well as in Puerto Rico and Chile.
Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be quarantined and not administered. Baxter Healthcare Corporation is the recalling firm and initiated the recall on August 6, 2026.
The recalled product
- Product
- FAMOTIDINE (FAMOTIDINE)
- Brand
- FAMOTIDINE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Injection
- Hazard
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 (4)
- Lot # NC188586
- Exp Date: 02/28/2027
- Lot # NC188913
- Exp Date: 3/9/2027.
Distribution
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