Why it was recalled
CGMP Deviations
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # NC188586, Exp Date: 02/28/2027; Lot # NC188913, Exp Date: 3/9/2027.
Where it was sold
US Nationwide; Puerto Rico; and Chile.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0809-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 6, 2026
- FDA report date
- Sep 9, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0809-2026, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 99500
- Address
- 1 Baxter Pkwy
- Code information
- Lot # NC188586, Exp Date: 02/28/2027; Lot # NC188913, Exp Date: 3/9/2027.
- Postal code
- 60015-4625
- Report date
- Sep 9, 2026
- Product type
- Drugs
- Recall number
- D-0809-2026
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- US Nationwide; Puerto Rico; and Chile.
- Recall initiation date
- Aug 6, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2026