Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sucralfate Tablets Recalled for Quality Control Deviations

Agency Publication Date: August 1, 2025
Share:
Sign in to monitor this recall

Summary

Nostrum Laboratories is recalling 60,608 bottles of Sucralfate (sucralfate) Tablets, USP 1 gram. The recall includes both 100-count and 500-count bottles. This action was taken because the company filed for bankruptcy and can no longer monitor its quality control programs, meaning they cannot guarantee the medication meets standards for identity, strength, quality, and purity.

Risk

Because the manufacturer cannot assure the quality of the drug, the products are considered adulterated. This could lead to patients receiving medication that is ineffective or does not contain the correct amount of active ingredient, potentially failing to treat the underlying gastrointestinal conditions for which it was prescribed.

What You Should Do

  1. The recalled products are Sucralfate Tablets, USP 1 gram, sold in 100-count bottles (NDC 29033-0003-01) and 500-count bottles (NDC 29033-0003-05) manufactured by Nostrum Laboratories, Inc. All lots within their expiry dates are affected.
  2. If you have health concerns after using this medication, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Nostrum Laboratories for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sucralfate Tablets, USP 1 gramby Nostrum Laboratories
Variants: 1 gram, Tablet, 100-count bottle, 500-count bottle
Lot Numbers:
All Lots within expiry dates
NDC:
29033-0003-01
29033-0003-05

Rx Only. Recalling firm filed for Chapter 11 in September 2024.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97053
Status: Active
Manufacturer: Nostrum Laboratories, Inc.
Sold By: Pharmacies; Healthcare Providers
Manufactured In: United States
Units Affected: 60,608 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.