Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Industries, Inc.: Testosterone Cypionate Injection Recalled for Particulate Matter Contamination

Agency Publication Date: July 24, 2018

Summary

Sun Pharmaceutical Industries, Inc. is recalling 5,215 vials of Testosterone Cypionate Injection, USP (200 mg/mL). This prescription medication is being recalled because organic and inorganic compounds were detected inside the 10 mL vials. These particulates were found during testing and could lead to serious health complications if the product is injected. This recall affects lot JKS0280A, which was distributed nationwide to pharmacies and healthcare providers within the United States.

Risk

The presence of organic and inorganic particulate matter in an injectable medication can cause local inflammation, granulomas, or more severe systemic complications such as blood vessel blockages (embolisms) if the particles enter the bloodstream.

What You Should Do

Check your medication vials for Testosterone Cypionate Injection, USP (200 mg/mL) in 10 mL vials with NDC 62756-016-40.
Verify the lot number and expiration date on the vial label: look for Lot #: JKS0280A with an expiration date of 06/2019.
Immediately stop using any product from this affected lot and set it aside in a secure location.
Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and to report if you have experienced any adverse effects.
Return any unused vials from the affected lot to the pharmacy or place of purchase for a refund and contact Sun Pharmaceutical Industries, Inc. for further return instructions.
For additional questions or to report safety concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider 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: Testosterone Cypionate Injection, USP, 200 mg/mL (10 mL vials)

Model:

NDC 62756-016-40

Recall #: D-0977-2018

Lot Numbers:

JKS0280A (Exp. 06/2019)

Date Ranges: 06/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80485

Status: Resolved

Manufacturer: Sun Pharmaceutical Industries, Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: India, United States

Units Affected: 5215 units

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.

Summary

What You Should Do

Check your medication vials for Testosterone Cypionate Injection, USP (200 mg/mL) in 10 mL vials with NDC 62756-016-40.

Verify the lot number and expiration date on the vial label: look for Lot #: JKS0280A with an expiration date of 06/2019.

Immediately stop using any product from this affected lot and set it aside in a secure location.

Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and to report if you have experienced any adverse effects.

Return any unused vials from the affected lot to the pharmacy or place of purchase for a refund and contact Sun Pharmaceutical Industries, Inc. for further return instructions.

For additional questions or to report safety concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).