Drug Recall: Pravastatin Sodium Due to Manufacturing Deviations
Glenmark Pharmaceuticals is recalling certain Pravastatin Sodium tablets nationwide due to manufacturing process deviations. Affected lots with expiration dates between March and November 2026 were distributed throughout the United States.
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 FDA Class II voluntary, firm-initiated recall has no reported illnesses or injuries. Manufacturing process deviations without a specified hazard type or reported harm, combined with the voluntary nature of the recall, classify as Moderate (2) per the rubric.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling certain Pravastatin Sodium Tablets 20mg distributed nationwide. The affected products include 500-count bottles (NDC# 68462-196-05) and 90-count bottles (NDC# 68462-196-90).
The recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) standards discovered in the manufacturing process. The company initiated the voluntary recall on March 13, 2025, and the FDA classified it as a Class II recall on April 8, 2025.
The affected lots include 17230810, 17230811, 17232501, and 17232502, with expiration dates between March 2026 and November 2026. The medication was manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India and distributed throughout the United States.
The recalled product
- Product
- PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Statin
- 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 (6)
- Lot # 17230810
- exp. date Mar-26 17230811
- exp. date Mar-26 17230810
- exp. date Mar-26 17232501
- exp. date Nov-26 17232502
- exp. date Nov-26
UPCs (2)
- 0368462195901
- 0368462198902
Distribution
Distributed nationwide across the United States.
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