Could cause temporary or reversible harm; serious harm is unlikely.
CGMP Deviations
| Brand name | FAMOTIDINE |
| Generic name | FAMOTIDINE |
| Active ingredient(s) | FAMOTIDINE |
| Distributed by / for | Baxter Healthcare Corporation |
| NDC | 0338-5197-41 |
| Full product label | Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41. |
| Recalling firm | Baxter Healthcare Corporation |
| Distribution | US Nationwide; Puerto Rico; and Chile. |
| Quantity | N/A |
| Recall initiated | 2026-08-06 |
| Report date | 2026-09-09 |
| Recall completed | — |
| Recall number | D-0809-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Deerfield IL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗