The Recall Desk
HighFDA (Drugs)·D-0547-2025·Announced 2025-08-06

Sucralfate Tablets Recalled Nationwide Due to CGMP Deviations

Nostrum Laboratories is recalling 60,608 bottles of Sucralfate Tablets nationwide. The manufacturer cannot assure the tablets meet required quality and purity standards due to Current Good Manufacturing Practice deviations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—inability to assure quality standards due to manufacturing deviations—rather than detected, so the maximum score per the rubric is 3 (High).

Plain-English summary

Sucralfate Tablets, USP 1 gram, are being recalled by Nostrum Laboratories, Inc. in two package sizes: 100-count bottles (NDC 29033-0003-01) and 500-count bottles (NDC 29033-0003-05). The recall affects approximately 60,608 bottles distributed nationwide within the United States. All lots within their expiry dates are included in the recall.

The recall results from Current Good Manufacturing Practice (CGMP) deviations caused by the firm's Chapter 11 bankruptcy filing in September 2024. As a result, the manufacturer cannot assure that products meet the required identity, strength, quality, and purity standards. The U.S. Food and Drug Administration has classified this as a Class II recall.

Consumers and healthcare providers who have Sucralfate Tablets from this recall should consult their healthcare provider about alternative treatment options. Healthcare facilities should quarantine affected products and return them to the manufacturer or distributor.

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
Hazard
  • cgmp-deviation
  • subpotency

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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