Nostrum Laboratories, Inc. has announced a voluntary nationwide recall of Sucralfate Tablets USP 1 gram. This decision comes after the company filed for Chapter 11 bankruptcy on September 30, 2024, leading to the shutdown of its operations and termination of employees at all domestic sites in the U.S.
The recall is specific to all lots of Sucralfate Tablets USP 1 gram manufactured after June 2023 and does not affect any other products by Nostrum Labs. These tablets were distributed to wholesalers, retailers, manufacturers, medical facilities, and repackagers. Due to the discontinuation of its quality program following operational closures, Nostrum Labs cannot ensure that these tablets meet their intended specifications through their labeled shelf life.
The company advises immediate cessation of distribution or use of this product and requests that distributors notify their subsidiaries and customers about the recall. All affected lots should be destroyed as returns are not being accepted by Nostrum Labs.
In a statement regarding risks associated with the recalled product, it was noted that "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 no adverse events have been reported related to this recall, patient risks from using an adulterated product cannot be ruled out.
Consumers with concerns or who experience issues related to this drug are encouraged to contact their healthcare provider. Additionally, adverse reactions can be reported via the FDA’s MedWatch Adverse Event Reporting program online or by mail/fax.
This recall has been conducted with the knowledge of the U.S. Food and Drug Administration.
