Lupin Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
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 rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported in the text, the presence of a carcinogenic impurity (NDMA) above acceptable levels in a Class II drug recall aligns with the Severe criteria for significant potential harm.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles. The product is prescription-only and was distributed throughout the United States. The recall involves 95,886 bottles with specific batch numbers listed in the source data.
The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. This is classified as a Current Good Manufacturing Practice (CGMP) deviation. The agency classification for this recall is Class II.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product is manufactured for Lupin Pharmaceuticals, Inc. and manufactured by Lupin Limited, Goa INDIA.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 95,886
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Lupin Pharmaceuticals 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 4 products in this recall →Related recalls
Same brand · METFORMIN HYDROCHLORIDE
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- SevereMetformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination
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- HighMetformin Hydrochloride Tablets Recalled for NDMA Contamination
FDA (Drugs) · 2021-06-30
- ModerateSun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Substance
FDA (Drugs) · 2021-05-19
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Same hazard · ndma impurity
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