Nostrum Laboratories Inc Product Recalls

Sucralfate Tablets (Nostrum Laboratories) – Quality Program Disruption (2025)

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.

Class IIModerate

FDAJul 11, 2025Nationwide• Nostrum Laboratories, Inc.

Metformin Hydrochloride Tablets (Nostrum) – NDMA Impurity (2021)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

Class IIModerate

FDAJan 25, 2021Nationwide• Nostrum Laboratories Inc

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Nostrum Laboratories, Inc. Recalls

Recall Summary

Sucralfate Tablets (Nostrum Laboratories) – Quality Program Disruption (2025)

Metformin Hydrochloride Tablets (Nostrum) – NDMA Impurity (2021)

Metformin Hydrochloride Tablets (Nostrum) – NDMA Impurity (2021)

Metformin HCL Extended-Release 500mg (Nostrum) – NDMA Impurity (2020)

Metformin HCL Extended-Release 750mg (Nostrum) – NDMA Impurity (2020)

Theophylline Extended-Release (Nostrum) – Labeling Errors (2020)

Calcium Acetate Capsules (Nostrum Laboratories) – Foreign Tablet Contamination (2018)

Nitrofurantoin Oral Suspension (Nostrum) – Failed Dissolution Test (2016)