Nostrum Laboratories recalls

Nostrum Laboratories has 8 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 6 Aug 2025. 5 are still ongoing. The most frequent reason is nitrosamine impurity.

Total recalls8since 2016

Last 12 months0reported

Class I00% of total

Ongoing5latest 6 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 1 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 7 88%Class III 1 13%

Why nostrum laboratories is recalled

Product types

Diabetes Medication450%
Antibiotics113%

By year

2025113%
2021225%
2020338%
2018113%
2016113%

Ongoing nostrum laboratories recalls

5 active

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025Drug	CLASS II	Sucralfate Tablets recalled by Nostrum Laboratories	Nostrum Laboratories	Manufacturing (CGMP) Deviations	Nationwide
10 Feb 2021Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide
20 Jan 2021Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide

All nostrum laboratories recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025Drug	CLASS II	Sucralfate Tablets recalled by Nostrum Laboratories	Nostrum Laboratories	Manufacturing (CGMP) Deviations	Nationwide
10 Feb 2021Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide
20 Jan 2021Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide
1 Apr 2020Drug	CLASS II	Theophylline (Anhydrous) Extended-Release Tablets, 400 mg recalled	Nostrum Laboratories	Labeling Errors	MO, TN
28 Feb 2018Drug	CLASS III	Calcium Acetate Capsules, 667 mg recalled by Nostrum Laboratories	Nostrum Laboratories	Other	Nationwide
22 Jun 2016Drug	CLASS II	Nitrofurantoin Oral Suspension, USP, 25 mg recalled	Nostrum Laboratories	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.