Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Lovastatin Tablets USP Recalled by American Health Packaging Due to CGMP Deviations: Finished product made with lovastatin drug...

Date: February 19, 2019
Company: American Health Packaging
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 American Health Packaging directly.

Affected Products

Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.

Quantity: 14,360 bottles

Why Was This Recalled?

CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About American Health Packaging

American Health Packaging has 56 total recalls tracked by RecallDetector.

Related Recalls

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