Nostrum Laboratories Inc. has issued a voluntary recall of all lots of Sucralfate Tablets USP 1 gram manufactured after June 2023, following the company's Chapter 11 bankruptcy filing and complete operational shutdown. The U.S. Food and Drug Administration announced the recall after Nostrum Labs terminated operational employees at all domestic U.S. sites and ceased quality control activities.
Recall Details and Scope
The recall affects all lots of the ulcer medication produced after June 2023, distributed to wholesalers, retailers, manufacturers, medical facilities, and repackagers across the United States. No other Nostrum Labs products are included in this recall action.
The company filed Chapter 11 bankruptcy in September 2024, leading to the cessation of all operations and termination of operational employees at domestic sites. Due to this closure and discontinuation of quality control activities, Nostrum Labs cannot assure that the product meets the identity, strength, quality, and purity characteristics it is purported to possess.
Safety Concerns and Patient Risk
According to the FDA recall notice, "While specific risks to patients from use of an adulterated product cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such a product." The discontinuation of the quality program means the company cannot guarantee that any lots still within expiry will meet all intended specifications through the labeled shelf life.
The recall notice emphasizes that "Further distribution or use of any remaining product on the market should cease immediately." No adverse events have been reported in connection with this recall.
Product Disposal and Consumer Actions
All lots of the recalled Sucralfate Tablets should be destroyed, as Nostrum Labs is not accepting returns of the product. The FDA has instructed that all lots should be destroyed rather than returned to the manufacturer.
Consumers who have experienced problems potentially related to the product should contact their healthcare provider immediately. For questions regarding the recall, customers can contact Nostrum Labs at recallcoordinator@nostrumlabsrecall.com.
Adverse Event Reporting
Patients experiencing adverse reactions or quality problems with the recalled product can report these issues to the FDA's MedWatch Adverse Event Reporting program through multiple channels:
- Online reporting at www.fda.gov/medwatch/report.htm
- Regular mail or fax using forms available at www.fda.gov/MedWatch/getforms.htm
- Phone requests for reporting forms at 1-800-332-1088
- Fax submissions to 1-800-FDA-0178
