Medications & Supplements/Prescription Drugs

InvaGen Pharmaceuticals, Inc.: Testosterone Cypionate Injections Recalled for Presence of Particulate Matter

Agency Publication Date: April 12, 2019

Summary

InvaGen Pharmaceuticals is recalling 780,740 vials of Testosterone Cypionate Injection (generic for Depo-Testosterone) because particulate matter was found in the vials. Injecting a product containing solid particles can lead to serious health issues, such as inflammation, allergic reactions, or blockages in blood vessels. Consumers who use these injections should contact their doctor or pharmacist immediately to determine if their specific supply is affected and to obtain a safe replacement. This recall includes multiple strengths and vial sizes distributed nationwide between December 2019 and December 2020.

Risk

The presence of solid particulate matter in an injectable medication can cause irritation or swelling at the injection site. If the particles enter the bloodstream, they may travel to the lungs or other organs, causing inflammation or blood clots that could lead to life-threatening complications.

What You Should Do

Check your medication packaging for the product name 'Testosterone Cypionate Injection, USP' and NDC numbers 69097-537-37, 69097-537-31, or 69097-536-37.
Verify if your lot number and expiration date are included in the recall. For the 2000 mg/10 mL vials (NDC 69097-537-37), check for lots GH80159 through GH81047 with expirations between 01/2020 and 08/2020. For 1 mL single-dose vials (NDC 69097-537-31), check for lots GH80009 through GH81311 with expirations between 12/2019 and 10/2020. For 1000 mg/10 mL vials (NDC 69097-536-37), check for lots GH80216, GH80322, GH80323, and GH90072 with expirations between 01/2020 and 12/2020.
Immediately stop using any affected medication and contact your healthcare provider or pharmacist for guidance on continuing your treatment.
Return any unused vials to the pharmacy where you purchased them for a refund.
Contact InvaGen Pharmaceuticals or the manufacturer, Cipla USA, Inc., at their corporate offices for further instructions regarding this recall.
For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Return product to place of purchase.

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, 2000 mg/10 mL (200 mg/mL), 10 mL Multiple-Dose Vial

Model:

NDC 69097-537-37

Recall #: D-1123-2019

Lot Numbers:

GH80159 (Exp 01/2020)

GH80160 (Exp 01/2020)

GH80161 (Exp 01/2020)

GH80489 (Exp 03/2020)

GH80490 (Exp 03/2020)

GH80502 (Exp 03/2020)

GH80503 (Exp 03/2020)

GH80504 (Exp 03/2020)

GH80557 (Exp 04/2020)

GH80598 (Exp 04/2020)

GH80601 (Exp 04/2020)

GH80602 (Exp 04/2020)

GH80845 (Exp 06/2020)

GH80846 (Exp 06/2020)

GH80855 (Exp 06/2020)

GH80856 (Exp 06/2020)

GH80857 (Exp 06/2020)

GH80877 (Exp 06/2020)

GH80903 (Exp 07/2020)

GH80908 (Exp 07/2020)

GH80931 (Exp 07/2020)

GH81047 (Exp 08/2020)

Date Ranges: January 2020 - August 2020

Product: Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-Dose Vial

Model:

NDC 69097-537-31

Recall #: D-1124-2019

Lot Numbers:

GH80009 (Exp 12/2019)

GH80010 (Exp 12/2019)

GH80011 (Exp 12/2019)

GH80568 (Exp 4/2020)

GH80575 (Exp 4/2020)

GH80579 (Exp 4/2020)

GH80580 (Exp 4/2020)

GH80581 (Exp 4/2020)

GH80582 (Exp 4/2020)

GH80646 (Exp 05/2020)

GH80664 (Exp 05/2020)

GH80665 (Exp 05/2020)

GH80684 (Exp 05/2020)

GH80699 (Exp 05/2020)

GH80700 (Exp 05/2020)

GH80701 (Exp 05/2020)

GH80746 (Exp 05/2020)

GH80761 (Exp 05/2020)

GH80765 (Exp 05/2020)

GH80777 (Exp 05/2020)

GH80801 (Exp 06/2020)

GH80823 (Exp 06/2020)

GH80828 (Exp 06/2020)

GH80878 (Exp 06/2020)

GH80967 (Exp 07/2020)

GH80968 (Exp 07/2020)

GH81033 (Exp 07/2020)

GH81034 (Exp 07/2020)

GH81042 (Exp 08/2020)

GH81154 (Exp 08/2020)

GH81255 (Exp 10/2020)

GH81256 (Exp 10/2020)

GH81288 (Exp 10/2020)

GH81289 (Exp 10/2020)

GH81310 (Exp 10/2020)

GH81311 (Exp 10/2020)

Date Ranges: December 2019 - October 2020

Product: Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Multiple-Dose Vial

Model:

NDC 69097-536-37

Recall #: D-1125-2019

Lot Numbers:

GH80216 (Exp 1/2020)

GH80322 (Exp 2/2020)

GH80323 (Exp 2/2020)

GH90072 (Exp 12/2020)

Date Ranges: January 2020 - December 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82463

Status: Resolved

Manufacturer: InvaGen Pharmaceuticals, Inc.

Sold By: pharmacies; hospitals

Manufactured In: India, United States

Units Affected: 3 products (12234 vials; 692538 vials; 75968 vials)

Distributed To: Nationwide

Agency Last Updated: April 24, 2019

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 packaging for the product name 'Testosterone Cypionate Injection, USP' and NDC numbers 69097-537-37, 69097-537-31, or 69097-536-37.

Verify if your lot number and expiration date are included in the recall. For the 2000 mg/10 mL vials (NDC 69097-537-37), check for lots GH80159 through GH81047 with expirations between 01/2020 and 08/2020. For 1 mL single-dose vials (NDC 69097-537-31), check for lots GH80009 through GH81311 with expirations between 12/2019 and 10/2020. For 1000 mg/10 mL vials (NDC 69097-536-37), check for lots GH80216, GH80322, GH80323, and GH90072 with expirations between 01/2020 and 12/2020.

Immediately stop using any affected medication and contact your healthcare provider or pharmacist for guidance on continuing your treatment.

Return any unused vials to the pharmacy where you purchased them for a refund.

Contact InvaGen Pharmaceuticals or the manufacturer, Cipla USA, Inc., at their corporate offices for further instructions regarding this recall.

For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), 10 mL Multiple-Dose Vial

Model:

NDC 69097-537-37

Recall #: D-1123-2019

Lot Numbers:

GH80159 (Exp 01/2020)

GH80160 (Exp 01/2020)

GH80161 (Exp 01/2020)

GH80489 (Exp 03/2020)

GH80490 (Exp 03/2020)

GH80502 (Exp 03/2020)

GH80503 (Exp 03/2020)

GH80504 (Exp 03/2020)

GH80557 (Exp 04/2020)

GH80598 (Exp 04/2020)

GH80601 (Exp 04/2020)

GH80602 (Exp 04/2020)

GH80845 (Exp 06/2020)

GH80846 (Exp 06/2020)

GH80855 (Exp 06/2020)

GH80856 (Exp 06/2020)

GH80857 (Exp 06/2020)

GH80877 (Exp 06/2020)

GH80903 (Exp 07/2020)

GH80908 (Exp 07/2020)

GH80931 (Exp 07/2020)

GH81047 (Exp 08/2020)

Date Ranges: January 2020 - August 2020

Product: Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-Dose Vial

Model:

NDC 69097-537-31

Recall #: D-1124-2019

Lot Numbers:

GH80009 (Exp 12/2019)

GH80010 (Exp 12/2019)

GH80011 (Exp 12/2019)

GH80568 (Exp 4/2020)

GH80575 (Exp 4/2020)

GH80579 (Exp 4/2020)

GH80580 (Exp 4/2020)

GH80581 (Exp 4/2020)

GH80582 (Exp 4/2020)

GH80646 (Exp 05/2020)

GH80664 (Exp 05/2020)

GH80665 (Exp 05/2020)

GH80684 (Exp 05/2020)

GH80699 (Exp 05/2020)

GH80700 (Exp 05/2020)

GH80701 (Exp 05/2020)

GH80746 (Exp 05/2020)

GH80761 (Exp 05/2020)

GH80765 (Exp 05/2020)

GH80777 (Exp 05/2020)

GH80801 (Exp 06/2020)

GH80823 (Exp 06/2020)

GH80828 (Exp 06/2020)

GH80878 (Exp 06/2020)

GH80967 (Exp 07/2020)

GH80968 (Exp 07/2020)

GH81033 (Exp 07/2020)

GH81034 (Exp 07/2020)

GH81042 (Exp 08/2020)

GH81154 (Exp 08/2020)

GH81255 (Exp 10/2020)

GH81256 (Exp 10/2020)

GH81288 (Exp 10/2020)

GH81289 (Exp 10/2020)

GH81310 (Exp 10/2020)

GH81311 (Exp 10/2020)

Date Ranges: December 2019 - October 2020

Product: Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Multiple-Dose Vial

Model:

NDC 69097-536-37

Recall #: D-1125-2019

Lot Numbers:

GH80216 (Exp 1/2020)

GH80322 (Exp 2/2020)

GH80323 (Exp 2/2020)

GH90072 (Exp 12/2020)

Date Ranges: January 2020 - December 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82463

Status: Resolved

Manufacturer: InvaGen Pharmaceuticals, Inc.

Sold By: pharmacies; hospitals

Manufactured In: India, United States

Units Affected: 3 products (12234 vials; 692538 vials; 75968 vials)

Distributed To: Nationwide

Agency Last Updated: April 24, 2019