Elevated risk U.S. Food and Drug Administration

Nostrum Laboratories Sucralfate Tablets USP 1 gram recall: Company closure and discontinuation of quality activities

Recall published 1+ years ago

Company closure and discontinuation of quality activities.

The hazard: Drug safety concern

The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

What the notice says: Company closure and discontinuation of quality activities.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
July 11, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Nostrum Laboratories
Product type
Prescription & OTC drugs

Products covered by this recall

Sucralfate Tablets USP 1 gram

What the company announced

NEW YORK, DC, UNITED STATES, July 11, 2025 / EINPresswire.com / -- Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfate Tablets USP 1 gram, all lots within expiry, as a result of the closures and discontinuation of its Quality activities.

This recall pertains only to Sucralfate Tablets USP 1 gram, all lots with expiry, manufactured by Nostrum Labs after June 2023. No other Nostrum Labs products are affected by this recall. Nostrum Labs distributed the product at issue here to wholesalers, retailers, manufacturers, medical facilities, and repackagers.

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.

Nostrum Labs is notifying its distributors and direct consignees for this product by email and U.S. mail and is requesting they immediately further notify their subsidiaries, individual receiving sites or warehouses, customers, retailers, and consumers. All lots of this product should be destroyed; Nostrum Labs is not accepting any returns of this product.

Risk Statement: 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. 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. Nostrum Labs has not received any reports of adverse events related to this recall.

Customers with questions regarding this recall can contact Nostrum Labs at [email protected] . Consumers should contact their physician or healthcare 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 gram

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Nostrum Laboratories — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

  1. Check the lot number on your pack against the codes listed above.
  2. Keep the carton; the lot number is often printed only on the outer pack.
  3. Report side effects you think the product caused to FDA MedWatch.
  4. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Nostrum Laboratories, Inc. — Consumers: [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Nostrum Laboratories prescription & otc drugs recalled?

Company closure and discontinuation of quality activities. Company closure and discontinuation of quality activities.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

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