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.
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.
Lot numbers, UPCs & expiration codes
All Lots within expiry dates.
Where it was sold
nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0547-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 11, 2025
- FDA report date
- Aug 6, 2025
- Quantity
- 60,608 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nostrum Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0547-2025, exactly as published.
Show all FDA fields
- City
- Bryan
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 97053
- Address
- 705 E Mulberry St
- Code information
- All Lots within expiry dates.
- Postal code
- 43506-1432
- Report date
- Aug 6, 2025
- Product type
- Drugs
- Recall number
- D-0547-2025
- Classification
- Class II
- Recalling firm
- Nostrum Laboratories, Inc.
- Product quantity
- 60,608 bottles
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- nationwide within the United States
- Recall initiation date
- Jul 11, 2025
- Initial firm notification
- Press Release
- Center classification date
- Jul 31, 2025