FDA recalls Glenmark Pravastatin Sodium tablets for manufacturing deviations
Glenmark Pharmaceuticals Inc. is recalling Pravastatin Sodium 80mg tablets nationwide due to CGMP manufacturing deviations. Affected lots distributed to U.S. pharmacies expire from August 2025 through August 2026.
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: This is a Class II pharmaceutical recall with no reported illnesses or injuries. The recall is based on CGMP manufacturing deviations without a specific identified consumer-facing hazard. Per the severity rubric, voluntary precautionary recalls receive a Moderate (2) score.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Pravastatin Sodium 80mg tablets in 90-count bottles distributed nationwide. The affected lots have expiration dates ranging from August 2025 through August 2026 and were manufactured by Glenmark Pharmaceuticals Limited in Pithampur, India.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. This is a voluntary, firm-initiated Class II recall. The firm notified the FDA on March 13, 2025, and the FDA formally classified the recall on April 8, 2025.
Patients currently taking affected lots should contact their pharmacy or healthcare provider for guidance. Pharmacies should identify and segregate potentially affected inventory based on lot number and expiration date.
The recalled product
- Product
- PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- 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 (10)
- Lot # 17221771
- exp. date Aug-25 17230930
- exp. date Apr-26 17230931
- exp. date Apr-26 17231252
- exp. date May-26 17231274
- exp. date May-26 17231855
- exp. date Aug-26 17231916
- exp. date Aug-26 17231917
- exp. date Aug-26 17231945
- exp. date Aug-26
UPCs (2)
- 0368462195901
- 0368462198902
Distribution
Distributed nationwide across the United States.
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