Metformin Hydrochloride Extended-Release Tablets Recalled for CGMP Deviations
Glenmark Pharmaceuticals Inc., USA is recalling Metformin Hydrochloride Extended-Release Tablets 1000mg due to manufacturing practice deviations. The recall affects 90-count bottles distributed nationwide and is voluntary.
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: The FDA classified this as Class II. The source does not report any illnesses, hospitalizations, or injuries. CGMP deviations are manufacturing-process issues without evidence of direct patient harm, placing this in the Moderate category.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Metformin Hydrochloride Extended-Release Tablets 1000mg distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected product is sold in 90-count bottles with NDC 68462-521-90.
The specific affected lots are Lot #17232088 and Lot #17232093, both with expiration date September 2025. The tablets are manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, and distributed by Glenmark Pharmaceuticals Inc. USA in Mahwah, New Jersey.
This is a voluntary, firm-initiated recall. Consumers should contact their healthcare provider or pharmacist if they have questions about their medication. The FDA classified this as a Class II recall, and the company initiated the recall on March 13, 2025.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Oral Tablet
- Hazard
- cgmp-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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