D-0547-2025 Class II Ongoing
FDA drug recall D-0547-2025 was initiated by Nostrum Laboratories, Inc. on Jul 11, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 60,608 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 6, 2025
- Initiation Date
- Jul 11, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60,608 bottles
Product description
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.
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.
Distribution pattern
nationwide within the United States
Code information
All Lots within expiry dates.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0547-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026