A nationwide recall alert has been issued for medications produced by a company that is shutting down operations, according to a notice posted by the U.S. Food & Drug Administration.
Nostrum Laboratories Inc. filed Chapter 11 bankruptcy in September 2024 — ceasing and shutting down operations and terminating operational employees at all domestic sites in the United States.
Due to this closure and discontinuation of quality control activities, the company is initiating a voluntary recall of all lots with expiration of Sucralfate Tablets USP 1 gram.
The discontinuation of the quality program means the company is unable to assure that this product meets the identity, strength, quality, and purity characteristics that it is purported or represented to possess.
“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,” stated the recall notice.
The medications under recall were manufactured by Nostrum Labs after June 2023, and were distributed to wholesalers, retailers, manufacturers, medical facilities, and repackagers.
No other products are affected by this recall, and there have been no reports of adverse events.
“It cannot be guaranteed that any lots of this product that are still within expiry will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately,” stated the recall notice.
All lots of this product should “be destroyed.” The company is not accepting any returns of this product.
Customers with questions regarding this recall can contact Nostrum Labs at recallcoordinator@nostrumlabsrecall.com.
Consumers should contact their physician or health-care provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
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