Nostrum Laboratories cannot guarantee the safety of Sucralfate Tablets USP 1 gram manufactured after June 2023.
Photo: AIArtistry/Adobe Stock
Sucralfate Tablets USP 1 gram are being voluntarily recalled by Nostrum Laboratories (Nostrum Labs), according to the FDA. The move comes after Nostrum Labs filed for Chapter 11 bankruptcy in September 2024, shutting down all operations and laying off all operational staff in its United States facilities. Due to this shutdown, the company no longer has an active Quality department that can oversee product safety and compliance for Sucralfate Tablets USP 1 gram.1
In veterinary medicine, sulfacrate is used off-label for treating ulcers and erosions in the mouth, esophagus, stomach, and small intestine of dogs, cats, ferrets, reptiles, birds, and horses. The short-acting drug helps ulcers heal by creating a coating over them that protects them from stomach acids. The most common adverse effect associated with sulfacrate use is constipation. Vomiting has also been reported, particularly in cats.2
The Nostrum Labs recall only applies to all Sucralfate Tablets USP lots within their expiration date that were manufactured by Nostrum Labs after June 2023. The product was distributed to wholesalers, retailers, manufacturers, medical facilities, and repackagers. No other products by Nostrum Labs are affected by the recall.1
According to a company announcement, Nostrum Labs cannot guarantee that its sucralfate tablets will continue to meet all of the product’s intended specifications for the rest of its shelf life. As a result, the use of any leftover product or distribution of it should stop immediately.
“The discontinuation of Nostrum Labs’ quality program means 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,” Nostrum Labs wrote in the announcement.1 “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.”
According to the company, there have been no reports of adverse events to date related to the recall. Nostrum Labs is informing via email and US mail all parties who may have received the product from them, including distributors and anyone the company shipped the tablets to directly. In addition, they are asking these parties to immediately notify their subsidiaries, individual receiving sites or warehouses, customers, retailers, and consumers.
“All lots of this product should be destroyed,” Nostrum Labs stated in its announcement.1
The company is not accepting any returns of the recalled tablets. Clients with questions about the recall can contact the company at recallcoordinator@nostrumlabsrecall.com. Veterinarians and other healthcare providers should be notified if patients taking the medication have experienced any issues that may be related to the drug.
Any adverse effects or quality problems related to the use of the recalled tablets can be reported to FDA’s MedWatch Adverse Event Reporting program through mail, fax, or online (www.fda.gov/medwatch/report.htm).
Individuals who prefer to report by mail or fax can download the necessary form at www.fda.gov/MedWatch/getforms.htm or request one by calling 1-800-332-1088. Once completed, the form can be mailed to the pre-addressed location or faxed to 1-800-FDA-0178.
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