Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-
Summary
The FDA issued a Class II for Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003- by Nostrum Laboratories, Inc.. Reason: 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.
Details
Source
Drug Recall
External ID
D-0547-2025
Action Date
2025-08-06
Status
Ongoing
Category
drug
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/Code Info: All Lots within expiry dates.
Quantity Affected: 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.
Distribution
nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-11
Company
Bryan, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 42 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nostrum Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nostrum Laboratories, Inc. have FDA actions?
This is the only FDA action we have on record for Nostrum Laboratories, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0547-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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