Class IIDrug
Famotidine Injection in Sodium Chloride Injection recall
Summary
Baxter Healthcare Corporation is recalling Famotidine Injection in Sodium Chloride Injection (drug). According to the FDA report, the reason is: CGMP Deviations. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- Product
- 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.
- Reason
- CGMP Deviations
- Lot / code info
- Lot # NC188586, Exp Date: 02/28/2027; Lot # NC188913, Exp Date: 3/9/2027.
- Quantity
- N/A
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Recalling company
- Baxter Healthcare Corporation, Deerfield, IL United States
- Recall started
- August 6, 2026
- FDA report date
- September 9, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0809-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Baxter Healthcare Corporation) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.