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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

SUN PHARMACEUTICAL INDUSTRIES INC: Testosterone Cypionate Injection Recalled for Incorrect Lot Number Labeling

Agency Publication Date: January 25, 2021
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Summary

Sun Pharmaceutical Industries Inc. is recalling 36,275 cartons of Testosterone Cypionate Injection, USP CIII (200mg/ml), because the lot number printed on the outer box is incorrect. The recall affects 1mL single-dose vials of the generic medication distributed nationwide. While the medicine itself is not defective, the incorrect labeling on the outer packaging can cause confusion and prevent patients from accurately identifying their medication batch during safety checks.

Risk

The incorrect lot number on the secondary packaging makes it difficult for consumers and healthcare providers to track the product's history or respond to potential future safety warnings. No injuries or adverse reactions have been reported in connection with this labeling error.

What You Should Do

  1. Check your medication packaging to see if you have Testosterone Cypionate Injection (200mg/ml) with NDC 62756-015-40.
  2. Identify if your product is from Lot JKX2553A, which may have an incorrect lot number printed on the outer carton.
  3. Contact your healthcare provider or pharmacist for guidance on whether to continue using the product or how to obtain a replacement.
  4. Return any unused product to your pharmacy or place of purchase for a refund.
  5. Contact Sun Pharmaceutical Industries Inc. through your pharmacist for further instructions regarding the return process.
  6. For additional questions, call 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

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

Affected Products

Product: Testosterone Cypionate Injection, USP CIII 200mg/ml (1mL Single-dose vial)
Model:
NDC 62756-015-40
Recall #: D-0242-2021
Lot Numbers:
JKX2553A

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87168
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Manufactured In: United States, India
Units Affected: 36,275 cartons
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.