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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 ClomiPRAMINE Hydrochloride Capsules Recalled for Impurity Specifications

Agency Publication Date: April 18, 2025
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Summary

Lupin Pharmaceuticals Inc. is recalling 2,724 bottles of clomiPRAMINE hydrochloride Capsules USP (25 mg), a prescription medication used to treat obsessive-compulsive disorder. This recall was initiated after a long-term stability study revealed that the medication was breaking down into an unspecified degradation product that exceeded safety specifications. The affected medication was distributed nationwide in 100-count bottles.

Risk

The presence of degradation products means the medication has begun to break down chemically, which can result in the drug being less effective or containing impurities that do not meet safety standards. Patients should consult their doctor to ensure their treatment remains effective.

What You Should Do

  1. This recall affects 100-count bottles of clomiPRAMINE hydrochloride Capsules USP, 25 mg (NDC 68180-492-01), specifically identifying lot number M300442 with an expiration date of 6/30/2025.
  2. 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.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

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: clomiPRAMINE hydrochloride Capsules USP (100-count bottle)
Variants: 25 mg
Lot Numbers:
M300442 (Exp 6/30/2025)
NDC:
68180-492-01

Rx only; Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD; Manufactured By: Lupin Limited, Nagpur, India

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96681
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 2724 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.