Medications & Supplements/Prescription Drugs

Lupin Rifampin Capsules Recalled for Being Subpotent

Agency Publication Date: April 5, 2024

Summary

Lupin Pharmaceuticals Inc. is recalling 26,352 bottles of Rifampin Capsules USP, 300mg (30-count bottles) because the medication was found to be subpotent. This means the drug may not contain the full amount of active ingredient required, which could lead to the medication being less effective than intended. This is a prescription antibiotic medication, and the recall affects one specific lot.

Risk

Subpotent medication may not effectively treat the infection for which it was prescribed, potentially leading to treatment failure or a worsening of the patient's medical condition.

What You Should Do

The recalled product is Lupin Pharmaceuticals Rifampin Capsules USP, 300mg, sold in 30-count bottles with NDC 6818-0659-06.
Identify if your medication is affected by checking the label for lot number A201064 and an expiration date of March 2024.
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 the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 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

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 USP, 300mg (30-count bottle)

Variants: 300mg, 30-count

Lot Numbers:

A201064 (Exp. March 2024)

NDC:

6818-0659-06

Rx only; Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland; Manufactured by Lupin Limited India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94271

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: Pharmacies

Manufactured In: India

Units Affected: 26,352 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 · 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.

Summary

What You Should Do

The recalled product is Lupin Pharmaceuticals Rifampin Capsules USP, 300mg, sold in 30-count bottles with NDC 6818-0659-06.

Identify if your medication is affected by checking the label for lot number A201064 and an expiration date of March 2024.

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 the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.