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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

Sun Pharmaceutical Industries, Inc.: Sumatriptan Succinate Tablets Recalled for Impurity Specifications

Agency Publication Date: January 13, 2020
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Summary

Sun Pharmaceutical Industries, Inc. is recalling approximately 207,969 units of Sumatriptan Succinate Tablets (50 mg and 100 mg), commonly used to treat migraine headaches. The recall was initiated because routine testing revealed that certain lots did not meet chemical impurity and degradation specifications, meaning the medication contained higher-than-allowed levels of related substances. Consumers should check their prescription bottles or blister packs for the specific lot numbers and expiration dates affected by this recall. You should contact your doctor or pharmacist to discuss your treatment and how to obtain a safe replacement.

Risk

The tablets failed to meet quality standards for impurities and degradation, which could potentially reduce the effectiveness of the medication or expose patients to unexpected substances resulting from chemical breakdown.

What You Should Do

  1. Check your Sumatriptan Succinate 50 mg prescription for NDC 62756-521-69 (9-count blister cards) with lot numbers JKU1939A, JKU1940A, or JKU1940B (Exp. 04/2022).
  2. Check your Sumatriptan Succinate 50 mg prescription for NDC 62756-521-88 (100-count bottles) with lot number JKT4175A (Exp. 11/2020).
  3. Check your Sumatriptan Succinate 100 mg prescription for NDC 62756-0522-69 (9-count blister cards) with lot numbers JKT4174A (Exp. 11/2021), JKU0622A (Exp. 01/2022), or JKU1308A (Exp. 02/2022).
  4. Contact your healthcare provider or pharmacist immediately for guidance on whether you should continue taking the medication or if you need a replacement prescription.
  5. Return any unused tablets from the affected lots to your pharmacy for a refund and contact Sun Pharmaceutical Industries, Inc. at 270 Prospect Plains Rd, Cranbury, New Jersey for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

Affected Products

Product: Sumatriptan Succinate Tablets (50 mg, 9-count blister card)
Model:
NDC 62756-521-69
Lot Numbers:
JKU1939A (Exp. 04/2022)
JKU1940A (Exp. 04/2022)
JKU1940B (Exp. 04/2022)
Date Ranges: Exp. 04/2022
Product: Sumatriptan Succinate Tablets (50 mg, 100-count bottle)
Model:
NDC 62756-521-88
Lot Numbers:
JKT4175A (Exp. 11/2020)
Date Ranges: Exp. 11/2020
Product: Sumatriptan Succinate Tablets (100 mg, 9-count blister card)
Model:
NDC 62756-0522-69
Lot Numbers:
JKT4174A (Exp. 11/2021)
JKU0622A (Exp. 01/2022)
JKU1308A (Exp. 02/2022)
Date Ranges: Exp. 11/2021, Exp. 01/2022, Exp. 02/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84570
Status: Resolved
Manufacturer: Sun Pharmaceutical Industries, Inc.
Sold By: 96 distributors; 1 repacker/relabeler
Manufactured In: United States
Units Affected: 2 products (384/100 count bottles; 207,585 blisters)
Distributed To: Nationwide
Agency Last Updated: January 22, 2020

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.