Nostrum Laboratories has shut down operations and issued a voluntary nationwide recall of its Sucralfate-brand tablets, a medication commonly used to treat and prevent ulcers in the digestive tract.
The recall affects all lots of the drug still within expiry and manufactured after June 2023, according to an July 14 FDA news release. The Kansas City, Mo.-based pharmaceutical firm filed for Chapter 11 protection in September 2024 and has since terminated all operations in the U.S.
Nostrum said it can no longer ensure the product meets required safety and quality standards. While no adverse events have been reported, the company advises that all distribution and use of the drug stop immediately.
Distributors are being asked to notify all recipients, but Nostrum is not accepting product returns, the release said.