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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

Taro Pharmaceuticals U.S.A., Inc.: Nortriptyline HCl Capsules Recalled for Manufacturing Process Deviations

Agency Publication Date: February 1, 2021
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Summary

Taro Pharmaceuticals is voluntarily recalling 44,256 bottles of Nortriptyline HCl (nortriptyline hydrochloride) Capsules, 10mg, due to deviations from Current Good Manufacturing Practice (CGMP) standards. This prescription antidepressant was distributed in bottles of 100 capsules across the United States. While no specific patient injuries have been reported, consumers should contact their healthcare provider or pharmacist if they have used this medication and have concerns.

Risk

The recall is due to manufacturing process deviations (CGMP deviations), which means the product may not meet the quality and purity standards required by the FDA. Using a drug that does not meet these standards could lead to variations in the medication's effectiveness or safety.

What You Should Do

  1. Identify your medication by checking the bottle for Nortriptyline HCl Capsules, 10mg, with NDC 51672-4001-1 and lot numbers AC05096, AC05098, or AC05099.
  2. Check the expiration date on your bottle to see if it matches the recalled date of 10/31/2022.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking this medication.
  4. Return any remaining capsules from the affected lots to your pharmacy to receive a refund.
  5. Contact Taro Pharmaceuticals U.S.A., Inc. at their Hawthorne, NY location for any specific questions regarding this manufacturing issue.
  6. For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare consultation and pharmacy refund.

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

Affected Products

Product: Nortriptyline HCl Capsules, USP equivalent to 10mg base (100-count bottle)
Model:
NDC 51672-4001-1
Recall #: D-0246-2021
Lot Numbers:
AC05096 (Exp 10/31/2022)
AC05098 (Exp 10/31/2022)
AC05099 (Exp 10/31/2022)
Date Ranges: 10/31/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87152
Status: Resolved
Manufacturer: Taro Pharmaceuticals U.S.A., Inc.
Sold By: Pharmacies
Manufactured In: Israel, United States
Units Affected: 44,256 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.