Nostrum Laboratories Inc

Complete recall history across all FDA and CPSC categories — 6 total recalls

Nostrum Laboratories Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (6)

FDA drug safety enforcement actions by Nostrum Laboratories Inc

Date Product Reason Class
Jan 25, 2021 Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets pe... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above th... Class II
Jan 4, 2021 Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets pe... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above th... Class II
Oct 23, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottl... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above th... Class II
Oct 23, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottl... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above th... Class II
Mar 6, 2020 Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, ... CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect... Class II
Feb 13, 2018 Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufact... Presence of Foreign Tablets/Capsules Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.