Nostrum Laboratories announced a voluntary recall of its Sucralfate Tablets 1g. The recalled medications had a manufacturing date of June 2023.

Nostrum Labs filed for bankruptcy in 2024. It cited the shutdown of its U.S. operations as one reason for the recall. The other reason was its inability to guarantee the product’s quality.

The drug recall includes all lots with expiry dates after June 2023. It also covers tablets used for the short-term treatment of active duodenal ulcers.

FDA Warns Against Product’s Quality

An FDA notice said Nostrum Lab’s closure discontinues its quality assurance program. This means the company can’t guarantee the medication meets FDA standards. These strict standards ensure a medication’s strength and quality.

The FDA notice is also a warning to patients. It emphasized the risks of using an adulterated product. It said it’s impossible to always identify or assess these risks. It’s also impossible to rule out patient risks over the use of such products.

There are no confirmed reports of adverse reactions to the recalled drug. The FDA is still urging caution among consumers. This is due to the uncertainty about the product’s integrity.

Recall Instructions for Distributors and Healthcare Facilities

Nostrum Labs’ recall affects wholesalers, retailers, and medical facilities. It also impacts manufacturers and repackagers.

The company isn’t accepting product returns anymore. It’s why the FDA is advising consumers to destroy the recalled product.

The recall doesn’t affect other Nostrum Labs products.

What Consumers Can Do

Consumers with concerns about the recall should contact Nostrum Labs. They can email the company at recallcoordinator@nostrumlabsrecall.com.Consumers can also contact the FDA’s MedWatch program at www.fda.gov/medwatch. They can report adverse reactions or quality issues.