Class III โ€” Low Risk

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

Simvastatin Tablets Recalled by Micro Labs Usa, Inc S Due to Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated...

Date: August 19, 2014
Company: Micro Labs Usa, Inc S
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 Micro Labs Usa, Inc S directly.

Affected Products

Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90

Quantity: 1,008 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.

Where Was This Sold?

This product was distributed to 1 state: NY

Affected (1 state)Not affected

About Micro Labs Usa, Inc S

Micro Labs Usa, Inc S has 6 total recalls tracked by RecallDetector.

Related Recalls

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