FDAFDA · Food and drugs·Recall number D-0547-2025
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.
Published August 6, 2025 · Recall initiated: July 11, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Nostrum Laboratories, Inc.
- Distributor
- nationwide within the United States
- Lot
- All Lots within expiry dates.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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