Why it was recalled
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Product description
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
Lot numbers, UPCs & expiration codes
Lot 1015038, Exp Date 07/31/2025, Lot 1015898, Exp Date 09/30/2025; Lot 1016873, Exp Date 10/31/2025 and Lot 1023398, Exp Date 07/31/2026.
Where it was sold
Nationwide
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-0598-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 29, 2025
- FDA report date
- Sep 3, 2025
- Quantity
- 26,992 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-0598-2025, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 97361
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot 1015038, Exp Date 07/31/2025, Lot 1015898, Exp Date 09/30/2025; Lot 1016873, Exp Date 10/31/2025 and Lot 1023398, Exp Date 07/31/2026.
- Postal code
- 43217-1188
- Report date
- Sep 3, 2025
- Product type
- Drugs
- Recall number
- D-0598-2025
- Classification
- Class II
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- 26,992 blister packs
- Reason for recall
- CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 29, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 22, 2025