Granules Pharmaceuticals Recalls Metformin Hydrochloride Extended-Release Tablets
Granules Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets due to FDA detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.
Plain-English summary
Granules Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, in 100-count and 500-count bottles. The recall affects specific lot numbers and expiration dates distributed nationwide in the United States.
The recall was initiated because FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. This finding represents a deviation from Current Good Manufacturing Practices (CGMP).
Consumers with these specific bottles should stop using the medication and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- METFORMIN (METFORMIN ER 500 MG)
- Brand
- METFORMIN
- Manufacturer
- Granules Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (2)
- 0370010491038
- 0370010492035
Distribution
Distributed nationwide across the United States.
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