CLASS II ONGOING Drug recall · Reported 6 Aug 2025 · FDA Enforcement Report
Sucralfate Tablets recalled by Nostrum Laboratories
Nostrum Laboratories is recalling Sucralfate Tablets, USP, distributed nationwide in the US. The recall was initiated on 11 Jul 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0547-2025
- FDA event ID
- 97053
- Recalling firm
- Nostrum Laboratories, Bryan, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jul 2025
- FDA classified
- 31 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 11 Jul 2025 | Recall initiated by company | |
| 31 Jul 2025 | Classified by FDA | +20 days |
| 6 Aug 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Product as listed by the FDA
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.
Where it was distributed
nationwide within the United States
Questions about this recall
Is Sucralfate Tablets, USP recalled?
Yes. Nostrum Laboratories recalled Sucralfate Tablets, USP on 11 Jul 2025. The recall is Class II and its status is Ongoing. Recall number D-0547-2025.
Why was it recalled?
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Which lots are affected?
All Lots within expiry dates.
Where was it sold?
nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nostrum Laboratories
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Theophylline (Anhydrous) Extended-Release Tablets, 400 mg recalled | Nostrum Laboratories | Labeling Errors | MO, TN |
Other Sucralfate recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sucralfate Tablets recalled by Amerisource Health Services | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sucralfate Tablets recalled by Amerisource Health Services | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate | VistaPharm | Sterility | Nationwide |
| Drug | CLASS II | Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate | VistaPharm | Potency & Assay | Nationwide |
| Drug | CLASS II | Sucralfate Oral Suspension recalled by DASH Pharmaceuticals | DASH Pharmaceuticals | Packaging Defects | Nationwide |