The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0547-2025·Announced 2025-08-06

Sucralfate tablets recalled because bankruptcy left the quality program unmonitored

Sucralfate Tablets USP 1 gram from Nostrum Laboratories are being recalled across all lots within expiry because the firm cannot monitor its quality program after filing for Chapter 11. 60,608 bottles affected.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall arising from an inability to assure quality rather than any defect found in the product itself.

Plain-English summary

Sucralfate Tablets, USP 1 gram, packaged in 100-count bottles (NDC 29033-0003-01) and 500-count bottles (NDC 29033-0003-05), prescription only, manufactured by Nostrum Laboratories, Inc. of Kansas City, Missouri, are being recalled across all lots within expiry dates. The action covers 60,608 bottles.

The stated reason is CGMP deviations: the recalling firm filed for Chapter 11 in September 2024, and as a result it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality and purity characteristics they are purported or represented to possess, rendering the products adulterated. The FDA classified the action as Class II. The source does not report any specific defect having been found in the product.

Distribution was nationwide within the United States.

Patients holding affected product should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the manufacturer.

The recalled product

Product
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
Manufacturer
Nostrum Laboratories, Inc.
Category
Drug — Oral tablet
Hazard
Affected units
60,608

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots within expiry dates.

Distribution

Distributed nationwide across the United States.

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