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Nostrum Laboratories Recalls
8 recalls on record · June 22, 2016 to August 6, 2025 · Drugs
Recalls by year
16
18
20
21
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 6, 2025DrugsFDA
Nostrum Laboratories, Inc. recalls Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-
Hazard: 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.
February 10, 2021DrugsFDA
Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
January 20, 2021DrugsFDA
Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
November 11, 2020DrugsFDA
Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Labor
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
November 11, 2020DrugsFDA
Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Labor
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
April 1, 2020DrugsFDA
Nostrum Laboratories Inc recalls Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laborator
Hazard: CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
February 28, 2018DrugsFDA
Nostrum Laboratories Inc recalls Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas C
Hazard: Presence of Foreign Tablets/Capsules
June 22, 2016DrugsFDA
Nostrum Laboratories, Inc. recalls Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle
Hazard: Failed Dissolution Specifications