FDA Recalls Pravastatin Sodium Tablets Due to Manufacturing Deviations
Glenmark Pharmaceuticals is recalling Pravastatin Sodium 20mg tablets nationwide due to manufacturing quality deviations. The voluntary recall was initiated on March 13, 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: This recall is FDA Class II and voluntary, based on manufacturing practice deviations. No illnesses, injuries, or hospitalizations have been reported, making the hazard theoretical rather than demonstrated.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Pravastatin Sodium Tablets, USP, 20mg in 90-count bottles distributed nationwide. The affected product has lot number 17230810 and an expiration date of March 2026.
The recall was initiated on March 13, 2025, due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall initiated by the manufacturer and classified as Class II by the FDA.
Patients who have this medication should contact their pharmacist or healthcare provider. The affected product can be identified by lot number 17230810 on the bottle. The primary NDC number is 16714-559-01.
No illnesses or injuries have been reported. The recall status is ongoing.
The recalled product
- Product
- PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription
- 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 (2)
- Lot # 17230810
- exp. date Mar-26
UPCs (3)
- 0316714570013
- 0316714559018
- 0316714560014
Distribution
Distributed nationwide across the United States.
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