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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lupin Rifampin Capsules Recalled for Impurity Presence

Agency Publication Date: August 16, 2022
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Summary

Lupin Pharmaceuticals Inc. is recalling 7,872 bottles of Rifampin (rifampin) Capsules, 150 mg, because an impurity called 1-Methyl-4-Nitroso Piperazine (MNP) was detected during testing. These capsules are a prescription medication used to treat tuberculosis and other bacterial infections. The affected 30-count bottles were distributed to pharmacies across the country. No injuries or adverse incidents have been reported in connection with this recall.

Risk

The impurity MNP is a type of nitrosamine that may increase the risk of cancer if people are exposed to it above acceptable levels over long periods of time. Patients should consult their doctor before stopping this medication, as the risks of untreated tuberculosis or infection may outweigh the risk of the impurity.

What You Should Do

  1. This recall affects Rifampin Capsules, USP, 150 mg, sold in 30-count HDPE bottles under the Lupin Pharmaceuticals, Inc. label.
  2. Identify affected products by looking for NDC 68180-658-06 and lot number A200170 with an expiration date of December 2023 on the bottle label.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Rifampin Capsules (150 mg)
Variants: 150 mg, 30 count HDPE bottles, Rx Only
Lot Numbers:
A200170 (Exp December 2023)
NDC:
68180-658-06

Recall #: D-1343-2022. Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90616
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 7,872/30 count bottles
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.