Lupin Recalls Metformin Hydrochloride Extended-Release 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 agency classification is FDA Class II, and the presence of NDMA impurity above acceptable intake levels in a prescription drug constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 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 due to Current Good Manufacturing Practice (CGMP) deviations. FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. The affected batches include G808293, G808284, G808285, G808343, G901201, G901202, G906915, G906913, G906914, G002135, and G002849.
Consumers with this medication should contact their healthcare provider for guidance on alternative treatment options. The total quantity recalled is 59,568 bottles.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 59,568
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0368180337072
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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