Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Pravastatin Sodium Tablets USP Recalled by Glenmark Pharmaceuticals Inc., USA Due to Presence Of Foreign Tablet: in a bottle of...

Date: March 25, 2019
Company: Glenmark Pharmaceuticals Inc., USA
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Glenmark Pharmaceuticals Inc., USA directly.

Affected Products

Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05

Quantity: 2076 500-count Bottles

Why Was This Recalled?

Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Glenmark Pharmaceuticals Inc., USA

Glenmark Pharmaceuticals Inc., USA has 139 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report