FDA Drugs recall ·
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles recall
- Recall number
- D-0547-2025
- Date
- (initiated July 11, 2025)
- Company / brand
- Nostrum Laboratories, Inc.
705 E Mulberry St, Bryan, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 60,608 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All Lots within expiry dates.
Distribution
nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0547-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.