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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Hetero Labs, Ltd. - Unit III: Simvastatin Tablets Recalled for Presence of a Metallic Razor Blade

Agency Publication Date: January 16, 2018
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Summary

Hetero Labs, Ltd. is recalling one lot of Simvastatin Tablets (40 mg), a prescription medication used to lower cholesterol. The recall was initiated after a metallic razor blade was discovered inside a single 1000-count bottle of the medication. This recall affects the 1000-count bulk bottles distributed nationwide under the Camber Pharmaceuticals, Inc. label.

Risk

The presence of a foreign metallic object like a razor blade in a medication bottle poses a severe risk of deep cuts or lacerations if a consumer reaches into the bottle. Additionally, there is a potential for serious internal injury or choking if any metal fragments from the blade contaminated the tablets and were unknowingly ingested.

What You Should Do

  1. Locate your bottle of Simvastatin Tablets, USP, 40 mg (1000-count) and check the label for the manufacturer Camber Pharmaceuticals, Inc. and NDC 31722-513-10.
  2. Check the side of the bottle for Lot Number E171280 with an expiration date of 06/19 (June 2019).
  3. If your bottle matches this lot number, contact your healthcare provider or pharmacist immediately to discuss alternative medication and ensure your treatment is not interrupted.
  4. Return any unused tablets from the affected lot to your pharmacy for a refund and further instructions.
  5. Contact the manufacturer, Hetero Labs, Ltd., or the distributor, Camber Pharmaceuticals, Inc., for more information regarding this recall.
  6. For additional questions or to report an incident, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Simvastatin Tablets, USP, 40 mg (1000-count bottle)
Model:
NDC 31722-513-10
Recall #: D-0223-2018
Lot Numbers:
E171280 (Exp 06/19)
Date Ranges: Exp 06/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78821
Status: Resolved
Manufacturer: Hetero Labs, Ltd. - Unit III
Sold By: Camber Pharmaceuticals, Inc.
Manufactured In: India
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.