Medications & Supplements/Prescription Drugs

Jubilant Cadista Pharmaceuticals, Inc.: Clomipramine Hydrochloride Capsules Recalled for Failed Quality Specifications

Agency Publication Date: November 24, 2020

Summary

Jubilant Cadista Pharmaceuticals is voluntarily recalling 4,416 bottles of clomipramine hydrochloride capsules (50 mg), a medication used to treat obsessive-compulsive disorder. The recall was initiated because the capsules failed to meet certain quality specifications for tablets or capsules, which could affect how the medication performs. These 30-count bottles were distributed nationwide and are available only by prescription.

Risk

The failure to meet manufacturing specifications means the medication may not dissolve or be absorbed as intended, potentially reducing the drug's effectiveness in managing symptoms.

What You Should Do

Check your medication bottle for Clomipramine Hydrochloride Capsules USP, 50 mg in a 30-count bottle (NDC 59746-711-30).
Identify if your bottle is affected by looking for Lot# 20P0141 with an expiration date of 02/2022.
Contact your healthcare provider or pharmacist immediately to discuss whether you should continue taking the medication or if you need a replacement prescription.
Return any unused capsules from the affected lot to the pharmacy where you purchased them for a refund.
Contact Jubilant Cadista Pharmaceuticals at 1-800-308-3985 or their distributor for further instructions regarding the return of this product.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Pharmacy refund and consultation

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

Affected Products

Product: clomiPRAMINE Hydrochloride Capsules USP (50 mg, 30-count bottle)

Model:

NDC 59746-711-30

Lot Numbers:

20P0141 (Exp. 02/2022)

Date Ranges: 02/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86698

Status: Resolved

Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 4,416 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

Check your medication bottle for Clomipramine Hydrochloride Capsules USP, 50 mg in a 30-count bottle (NDC 59746-711-30).

Identify if your bottle is affected by looking for Lot# 20P0141 with an expiration date of 02/2022.

Contact your healthcare provider or pharmacist immediately to discuss whether you should continue taking the medication or if you need a replacement prescription.

Return any unused capsules from the affected lot to the pharmacy where you purchased them for a refund.

Contact Jubilant Cadista Pharmaceuticals at 1-800-308-3985 or their distributor for further instructions regarding the return of this product.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).