Micro Labs Usa, Inc S Simvastatin Tablets Recall: FDA Class III

Why it was recalled

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Product description

Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.

Lot numbers, UPCs & expiration codes

Lot #: STEG004, Exp 2/2015; Lot #: STEG006 Exp 3/2015

Where it was sold

Nationwide.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0409-2015
Classification: Class III
Status: Terminated
Recall initiated: Dec 4, 2014
FDA report date: Mar 18, 2015
Quantity: 13464 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Micro Labs Usa, Inc S

Original FDA data

Every field from FDA enforcement report D-0409-2015, exactly as published.

Show all FDA fields

City: Princeton
State: NJ
Status: Terminated
Country: United States
Event ID: 69928
Address: 104 Carnegie Ctr
Address (line 2): Te 216
Code information: Lot #: STEG004, Exp 2/2015; Lot #: STEG006 Exp 3/2015
Postal code: 08540-6232
Report date: Mar 18, 2015
Product type: Drugs
Recall number: D-0409-2015
Classification: Class III
Recalling firm: Micro Labs Usa, Inc S
Product quantity: 13464 bottles
Termination date: Apr 25, 2018
Reason for recall: Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
Distribution pattern: Nationwide.
Recall initiation date: Dec 4, 2014
Initial firm notification: E-Mail
Center classification date: Mar 11, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0409-2015, published Mar 18, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Micro Labs Usa, Inc S Simvastatin Tablets Recall

Summary