Lupin Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.
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, which corresponds to a Severe severity score (4) under the rubric, particularly given the detection of a carcinogenic impurity (NDMA) above acceptable levels.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles. The product is a prescription-only medication manufactured by Lupin Limited in Goa, India, and distributed throughout the United States.
The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. The affected product includes 64,344 bottles with specific batch numbers and expiration dates ranging from August 2020 to February 2022.
Consumers and healthcare providers should check their inventory for the specific NDC numbers and batch codes listed in the recall notice. Patients should consult their healthcare provider for alternative treatment options if they are currently taking the affected medication.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 64,344
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
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Same hazard · ndma impurity
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