Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because the NDMA impurity level exceeds acceptable intake limits.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of NDMA above acceptable intake levels represents a significant health risk, meeting the criteria for a Severe rating.
Plain-English summary
Nostrum Laboratories, Inc. is recalling 12,967 bottles of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (NDC 29033-056-01). The affected products are 100-count bottles marked with lot codes MET200101 and MET200301, with an expiration date of 05/2022. The recall is nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. NDMA is a potential carcinogen that is strictly regulated in pharmaceutical products.
Consumers and healthcare providers should stop using the affected medication and contact their healthcare provider for guidance on alternative treatment options. Patients should not discontinue their medication without consulting a healthcare professional.
The recalled product
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
- Manufacturer
- Nostrum Laboratories Inc
- Category
- Drug — Prescription Medication
- Affected units
- 12,967
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- MET200101
- MET200301 EXP 05/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Nostrum Laboratories Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Nostrum Laboratories Inc
See all →- ModerateSucralfate tablets recalled because bankruptcy left the quality program unmonitored
FDA (Drugs) · 2025-08-06
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2021-02-10
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2021-01-20
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-11-11
- ModerateNostrum Recalls Theophylline Tablets Due to Incorrect Lot and Expiration Dates
FDA (Drugs) · 2020-04-01
Same hazard · ndma impurity
See all →- SeverePreferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets
FDA (Drugs) · 2021-05-26
- SevereDenton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-11-11
- SevereDirect Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity
FDA (Drugs) · 2020-11-11
- SeverePD-Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity
FDA (Drugs) · 2020-11-11