PlainRecalls
FDA Drug Moderate Class II Ongoing

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]

Reported: September 3, 2025 Initiated: July 29, 2025 #D-0598-2025

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]

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.

Details

Units Affected
26,992 blister packs
Distribution
Nationwide
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
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]. Recalled by Amerisource Health Services LLC. Units affected: 26,992 blister packs.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 3, 2025. Severity: Moderate. Recall number: D-0598-2025.