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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 Testosterone Cypionate Injection Recalled for Water Leakage

Agency Publication Date: July 11, 2022
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Summary

Sun Pharmaceutical Industries Inc. is recalling approximately 50,860 vials of Testosterone Cypionate Injection (200mg/mL), a CIII controlled substance. The recall was initiated because of water leakage occurring during the manufacturing process, which violates current Good Manufacturing Practice (cGMP) standards. This recall affects 1mL single-dose vials distributed nationwide across the United States. No injuries or adverse incidents have been reported in connection with this issue.

Risk

Water leakage in a pharmaceutical manufacturing environment can lead to potential contamination or a loss of sterility. For an injectable medication, compromised sterility poses a risk of infection or other serious health complications for the patient.

What You Should Do

  1. This recall affects Sun Pharmaceutical Testosterone Cypionate Injection, USP (200mg/mL, 1mL single-dose vial) with NDC 62756-015-40 and lot number HAC4337A.
  2. If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist immediately.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc. directly for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

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: Testosterone Cypionate Injection, USP (200mg/mL)
Variants: 1mL Single-dose vial, CIII, Rx only
Lot Numbers:
HAC4337A
NDC:
62756-015-40

Quantity: 50,860 vials

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90451
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: pharmacies; healthcare providers
Manufactured In: India, United States
Units Affected: 50860 vials
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 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.