Nostrum Laboratories recalls
FDA enforcement reports naming Nostrum Laboratories Inc as the recalling firm.
- Recall reports
- 8
- Class I (serious)
- 0
- Most recent report
- Aug 6, 2025
- Aug 6, 2025Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and…Drug · Nostrum Laboratories, Inc.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 chara…Class II
- Feb 10, 2021Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle,…Drug · Nostrum Laboratories IncCGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.Class II
- Jan 20, 2021Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle,…Drug · Nostrum Laboratories IncCGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelClass II
- Nov 11, 2020Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx OnlyDrug · Nostrum Laboratories IncCGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelClass II
- Nov 11, 2020Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx OnlyDrug · Nostrum Laboratories IncCGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelClass II
- Apr 1, 2020Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, M…Drug · Nostrum Laboratories IncCGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.Class II
- Feb 28, 2018Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx OnlyDrug · Nostrum Laboratories IncPresence of Foreign Tablets/CapsulesClass III
- Jun 22, 2016Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIB…Drug · Nostrum Laboratories, Inc.Failed Dissolution SpecificationsClass II