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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

Leading Pharma ClomiPRAMINE Capsules Recalled for High Potency

Agency Publication Date: September 28, 2022
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Summary

Leading Pharma, LLC has recalled 960 bottles of ClomiPRAMINE Hydrochloride (clomipramine) Capsules, 25mg. The recall was issued because testing revealed the medication is "superpotent," containing 110.6% of the active ingredient instead of the intended amount. The affected 100-count bottles are labeled with NDC 69315-167-01 and belong to lot B14221. While no injuries have been reported, consumers should check their medication to see if it is part of this specific batch.

Risk

Taking a superpotent drug means the patient receives a higher dose of the medication than their doctor prescribed, which could lead to an accidental overdose or an increase in the frequency and severity of side effects.

What You Should Do

  1. The recalled product is Leading Pharma ClomiPRAMINE Hydrochloride Capsules, USP 25mg, sold in 100-count bottles with NDC 69315-167-01.
  2. Check your medication bottle for lot number B14221 with an expiration date of 02/2023.
  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 Leading Pharma, LLC 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: ClomiPRAMINE Hydrochloride Capsules, USP 25mg (100-count bottle)
Variants: 25mg, 100 capsules
Lot Numbers:
B14221 (Exp 02/2023)
NDC:
69315-167-01

Rx only; Manufactured by Leading Pharma, LLC in Fairfield, NJ

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90853
Status: Resolved
Manufacturer: Leading Pharma, LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 960 bottles (100 capsules)
Distributed To: Nationwide

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.