Home / Recalls / Nostrum Laboratories, Inc. / D-0547-2025

D-0547-2025 Class II Ongoing

Recalled by Nostrum Laboratories, Inc. — Bryan, OH

Recall Details

Product Type
Drugs
Report Date
August 6, 2025
Initiation Date
July 11, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60,608 bottles

Product Description

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.

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.

Distribution Pattern

nationwide within the United States

Code Information

All Lots within expiry dates.

Other recalls by Nostrum Laboratories, Inc.

  • D-0249-2021 Class II — Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per b (January 25, 2021)
  • D-0227-2021 Class II — Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per b (January 4, 2021)
  • D-0068-2021 Class II — Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, (October 23, 2020)
  • D-0067-2021 Class II — Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, (October 23, 2020)
  • D-1059-2020 Class II — Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx (March 6, 2020)
  • D-0473-2018 Class III — Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufacture (February 13, 2018)
  • D-1030-2016 Class II — Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRAC (May 23, 2016)