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.

Simvastatin USP 20 mg Recalled by PD-Rx Pharmaceuticals, Inc. Due to CGMP deviations.

Date: April 6, 2023
Company: PD-Rx Pharmaceuticals, Inc.
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 PD-Rx Pharmaceuticals, Inc. directly.

Affected Products

Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)

Quantity: 520 bottles

Why Was This Recalled?

CGMP deviations.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About PD-Rx Pharmaceuticals, Inc.

PD-Rx Pharmaceuticals, Inc. has 25 total recalls tracked by RecallDetector.

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