Nostrum Laboratories recalls 100-count and 500-count Sucralfate Tablets (USP 1 gram) due to CGMP deviations causing potential adulteration. Products may not meet quality standards as the company filed for Chapter 11 in September 2024.
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.
Nostrum Laboratories is recalling certain Sucralfate Tablets because the company filed for Chapter 11 bankruptcy in September 2024, which means they can no longer ensure the products meet quality standards. This could make the tablets adulterated and unsafe for use.
The company filed for Chapter 11 bankruptcy in September 2024, which means they can no longer monitor quality control. This could result in tablets that don't meet the required standards for identity, strength, quality, and purity, making them adulterated.
People who have the 100-count or 500-count Sucralfate Tablets (USP 1 gram) with NDC numbers 29033-0003-01 or 29033-0003-05. Those who use these prescription tablets for gastrointestinal issues are most at risk.
Check for 100-count bottles labeled NDC 29033-0003-01 or 500-count bottles labeled NDC 29033-0003-05. These are prescription-only Sucralfate Tablets (USP 1 gram) sold by Nostrum Laboratories.
Look for the NDC numbers 29033-0003-01 or 29033-0003-05 on the packaging of the Sucralfate Tablets.
Nostrum Laboratories filed for Chapter 11 bankruptcy in September 2024, which means they can no longer ensure the products meet quality standards, potentially making them adulterated.
The recall record does not specify a remedy, so you should check with your healthcare provider or pharmacist for advice.
The recall is due to potential adulteration from the company's inability to monitor quality after bankruptcy, but no specific safety risks are mentioned.
We’ve drafted a message you can send Nostrum Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0547-2025 — Nostrum Laboratories Nostrum Laboratories Hello, I own a Nostrum Laboratories that is covered by recall D-0547-2025 from Nostrum Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
