Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Testosterone Cypionate Injection Recalled for Sterility Issues

Agency Publication Date: June 22, 2022
Share:
Sign in to monitor this recall

Summary

Sun Pharmaceutical Industries Inc. is voluntarily recalling approximately 47,500 vials of Testosterone Cypionate Injection (200 mg/mL). The recall was initiated due to a manufacturing deviation that resulted in a microbial excursion, meaning the sterility of the product cannot be guaranteed. No injuries or adverse incidents have been reported to date. This prescription medication is used for testosterone replacement therapy and was distributed nationwide in the United States.

Risk

Using a medication intended for injection that is not sterile can lead to serious health complications, including localized infections or life-threatening systemic infections like sepsis. While no illnesses have been reported, the manufacturing defect poses a potential risk to anyone who receives an injection from the affected batch.

What You Should Do

  1. This recall affects Sun Pharmaceutical Industries Inc. Testosterone Cypionate Injection, USP, 200 mg/mL, sold in 1 mL single-dose vials with NDC 62756-015-40.
  2. Identify your product by checking for lot number HAC3427A with an expiration date of 08/2023 printed on the vial or carton.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

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 (200 mg/mL, 1 mL Single-dose vial)
Variants: 200 mg/mL, 1 mL Single-dose vial, Rx only
Lot Numbers:
HAC3427A (Exp 08/2023)
NDC:
62756-015-40

Recall #: D-1154-2022; Manufactured by Sun Pharmaceutical Industries Ltd., Gujarat, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90391
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Pharmacies; Hospitals; Wholesalers; Distributors
Manufactured In: India, United States
Units Affected: 47,500 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.