Metformin Tablets Recalled Due to Manufacturing Practice Deviations
Glenmark Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release 1000mg tablets nationwide due to manufacturing process deviations. Affected lots 17232088 and 17232093 expire September 2025.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II voluntary precautionary recall based on manufacturing practice deviations with no reported illnesses or injuries. The hazard is manufacturing process-related, not a specific identified contamination or defect.
Plain-English summary
Glenmark Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 1000mg (NDC 68462-521-90) distributed nationwide. The company identified deviations from Current Good Manufacturing Practices (CGMP) in the manufacturing process and initiated the recall voluntarily.
The affected lots are 17232088 and 17232093, both expiring September 2025. The 90-count bottles were manufactured in India and distributed throughout the United States. The company began the recall on March 13, 2025.
Consumers with affected medication should contact their pharmacy or healthcare provider. Do not use the recalled product. The FDA has classified this as a Class II recall.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Diabetes Medication
- Hazard
- manufacturing-deviation
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 (3)
- Lot # 17232088
- exp. date Sep-25 17232093
- exp. date Sep-25
UPCs (2)
- 0368462521908
- 0368462520017
Distribution
Distributed nationwide across the United States.
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