Sucralfate Tablets recall
FDA recall D-0547-2025 · initiated Jul 11, 2025
Nostrum Laboratories, Inc. recalled Sucralfate Tablets in Jul 2025 — an FDA Class II recall (D-0547-2025) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was 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.
Sold unapproved, or found to contain something undeclared
The product should not have been on sale in this form — often a supplement found to contain a hidden prescription drug.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 60,608 bottles
Details
- 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.
- Recalling company
- Nostrum Pharms LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- nationwide within the United States
- Initiated
- Jul 11, 2025
- FDA report date
- Aug 6, 2025
Frequently asked
- Was Sucralfate Tablets recalled?
- Nostrum Laboratories, Inc. recalled Sucralfate Tablets in Jul 2025 — an FDA Class II recall (D-0547-2025) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Sucralfate Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0547-2025 was: 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.
- Is a recalled Sucralfate Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sucralfate Tablets are affected?
- Distributed: nationwide within the United States. The recall covers these lots — All Lots within expiry dates.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0547-2025.