Recalls / Class II
Class IID-0598-2025
Product
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]
- Brand name
- Sucralfate
- Generic name
- Sucralfate
- Active ingredient
- Sucralfate
- Route
- Oral
- NDC
- 60687-695
- FDA application
- ANDA074415
- Affected lot / code info
- 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.
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.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 26,992 blister packs
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2025-07-29
- FDA classified
- 2025-08-22
- Posted by FDA
- 2025-09-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0598-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.