Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Industries, Inc.: Testosterone Cypionate Injection Recalled for Manufacturing Deviations

Agency Publication Date: January 16, 2020

Summary

Sun Pharmaceutical Industries, Inc. is voluntarily recalling multiple lots of Testosterone Cypionate for Injection due to manufacturing deviations. The company discovered that these released lots were produced under conditions similar to a previous batch that failed quality testing for being 'Out of Specification' (OOS). Consumers who use this prescription medication should check their vials immediately to see if they are part of the affected batches, which include both 1,000 mg/10 mL and 2,000 mg/10 mL concentrations. Because this is an injectable medication, manufacturing deviations could impact the safety or efficacy of the drug.

Risk

The products were manufactured under conditions that failed to meet Current Good Manufacturing Practice (cGMP) standards, specifically relating to a previously rejected lot that did not meet quality specifications. Using a medication produced under non-compliant manufacturing conditions may pose a risk to patient health if the drug's potency or purity was compromised.

What You Should Do

Check your medication vials for Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL) in 10 mL Multiple Dose Vials (NDC 62756-017-40) with the following lot numbers and expiration dates: JKT0933A, JKT0935A, JKT1062A (Mar-20); JKT1425A, JKT1483A (Apr-20); JKT1575A, JKT1729A, JKT1730A, JKT1728A (May-20); JKT2002A (Jun-20); JKT3216A, JKT3217A (Sep-20); JKT3589A, JKT3590A, JKT3626A (Oct-20); JKT3864A, JKT3935A (Dec-20).
Check your medication vials for Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL) in 1 mL Single Use Vials (NDC 62756-015-40) or 10 mL Multiple Dose Vials (NDC 62756-016-40). For 1 mL vials, look for lots including JKT0075A through JKU1044A with expiration dates ranging from Jan-20 to Feb-21. For 10 mL vials, look for lots JKT1862A through JKU0358A with expiration dates between May-20 and Dec-20.
If your lot number matches any of those listed, contact your healthcare provider or pharmacist immediately for guidance on whether to continue your treatment or to obtain a replacement.
Return any unused, recalled product to the pharmacy or place of purchase for a refund and contact Sun Pharmaceutical Industries, Inc. at 270 Prospect Plains Rd, Cranbury, NJ for further instructions.
For additional questions or to report adverse reactions, 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

Drug recall baseline remedy

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 for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial

Model:

NDC 62756-017-40

Recall #: D-0787-2020

Lot Numbers:

JKT0933A (Exp Mar-20)

JKT0935A (Exp Mar-20)

JKT1062A (Exp Mar-20)

JKT1425A (Exp Apr-20)

JKT1483A (Exp Apr-20)

JKT1575A (Exp May-20)

JKT1729A (Exp May-20)

JKT1730A (Exp May-20)

JKT1728A (Exp May-20)

JKT2002A (Exp Jun-20)

JKT3216A (Exp Sep-20)

JKT3217A (Exp Sep-20)

JKT3589A (Exp Oct-20)

JKT3590A (Exp Oct-20)

JKT3626A (Exp Oct-20)

JKT3864A (Exp Dec-20)

JKT3935A (Exp Dec-20)

Date Ranges: March 2020, April 2020, May 2020, June 2020, September 2020, October 2020, December 2020

Product: Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), 1 mL Single Use vial

Model:

NDC 62756-015-40

Recall #: D-0788-2020

Lot Numbers (87):

JKT0075A (Exp Jan-20)

JKT0076A (Exp Jan-20)

JKT0213A (Exp Jan-20)

JKT0215A (Exp Jan-20)

JKT0369A (Exp Jan-20)

JKT0214A (Exp Jan-20)

JKT0368A (Exp Jan-20)

JKT0370A (Exp Jan-20)

JKT0371A (Exp Feb-20)

JKT0515A (Exp Feb-20)

JKT0514A (Exp Feb-20)

JKT0516A (Exp Feb-20)

JKT0518A (Exp Feb-20)

JKT0517A (Exp Feb-20)

JKT0694A (Exp Feb-20)

JKT0695A (Exp Feb-20)

JKT0696A (Exp Feb-20)

JKT0697A (Exp Mar-20)

JKT0698A (Exp Mar-20)

JKT1063A (Exp Mar-20)

JKT1064A (Exp Mar-20)

JKT1065A (Exp Mar-20)

JKT1148A (Exp Mar-20)

JKT1068A (Exp Mar-20)

JKT1146A (Exp Mar-20)

JKT1066A (Exp Mar-20)

JKT1149A (Exp Apr-20)

JKT1147A (Exp Apr-20)

JKT1150A (Exp Apr-20)

JKT1427A (Exp Apr-20)

JKT1428A (Exp Apr-20)

JKT1426A (Exp Apr-20)

JKT1429A (Exp Apr-20)

JKT1540A (Exp Apr-20)

JKT1539A (Exp Apr-20)

JKT1541A (Exp Apr-20)

JKT1543A (Exp Apr-20)

JKT1542A (Exp Apr-20)

JKT1725A (Exp May-20)

JKT1574A (Exp May-20)

JKT1727A (Exp May-20)

JKT1863A (Exp May-20)

JKT1864A (Exp May-20)

JKT1865A (Exp May-20)

JKT1726A (Exp May-20)

JKT2191A (Exp Jun-20)

JKT1866A (Exp Jul-20)

JKT2192A (Exp Jul-20)

JKT2193A (Exp Jul-20)

JKT2194A (Exp Jul-20)

Date Ranges: January 2020, February 2020, March 2020, April 2020, May 2020, June 2020, July 2020, August 2020, September 2020, October 2020, November 2020, December 2020, February 2021

Product: Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), 10 mL Multiple Dose Vial

Model:

NDC 62756-016-40

Recall #: D-0788-2020

Lot Numbers:

JKT1862A (Exp May-20)

JKT1578A (Exp May-20)

JKT2000A (Exp Jun-20)

JKT1999A (Exp Jun-20)

JKT2001A (Exp Jun-20)

JKT2593A (Exp Jul-20)

JKT2594A (Exp Jul-20)

JKT3863A (Exp Nov-20)

JKT4013A (Exp Nov-20)

JKU0037A (Exp Dec-20)

JKU0038A (Exp Dec-20)

JKU0358A (Exp Dec-20)

Date Ranges: May 2020, June 2020, July 2020, November 2020, December 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84672

Status: Resolved

Manufacturer: Sun Pharmaceutical Industries, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

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

Risk

What You Should Do

Check your medication vials for Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL) in 10 mL Multiple Dose Vials (NDC 62756-017-40) with the following lot numbers and expiration dates: JKT0933A, JKT0935A, JKT1062A (Mar-20); JKT1425A, JKT1483A (Apr-20); JKT1575A, JKT1729A, JKT1730A, JKT1728A (May-20); JKT2002A (Jun-20); JKT3216A, JKT3217A (Sep-20); JKT3589A, JKT3590A, JKT3626A (Oct-20); JKT3864A, JKT3935A (Dec-20).

Check your medication vials for Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL) in 1 mL Single Use Vials (NDC 62756-015-40) or 10 mL Multiple Dose Vials (NDC 62756-016-40). For 1 mL vials, look for lots including JKT0075A through JKU1044A with expiration dates ranging from Jan-20 to Feb-21. For 10 mL vials, look for lots JKT1862A through JKU0358A with expiration dates between May-20 and Dec-20.

If your lot number matches any of those listed, contact your healthcare provider or pharmacist immediately for guidance on whether to continue your treatment or to obtain a replacement.

Return any unused, recalled product to the pharmacy or place of purchase for a refund and contact Sun Pharmaceutical Industries, Inc. at 270 Prospect Plains Rd, Cranbury, NJ for further instructions.

For additional questions or to report adverse reactions, 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 for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial

Model:

NDC 62756-017-40

Recall #: D-0787-2020

Lot Numbers:

JKT0933A (Exp Mar-20)

JKT0935A (Exp Mar-20)

JKT1062A (Exp Mar-20)

JKT1425A (Exp Apr-20)

JKT1483A (Exp Apr-20)

JKT1575A (Exp May-20)

JKT1729A (Exp May-20)

JKT1730A (Exp May-20)

JKT1728A (Exp May-20)

JKT2002A (Exp Jun-20)

JKT3216A (Exp Sep-20)

JKT3217A (Exp Sep-20)

JKT3589A (Exp Oct-20)

JKT3590A (Exp Oct-20)

JKT3626A (Exp Oct-20)

JKT3864A (Exp Dec-20)

JKT3935A (Exp Dec-20)

Date Ranges: March 2020, April 2020, May 2020, June 2020, September 2020, October 2020, December 2020

Product: Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), 1 mL Single Use vial

Model:

NDC 62756-015-40

Recall #: D-0788-2020

Lot Numbers (87):

JKT0075A (Exp Jan-20)

JKT0076A (Exp Jan-20)

JKT0213A (Exp Jan-20)

JKT0215A (Exp Jan-20)

JKT0369A (Exp Jan-20)

JKT0214A (Exp Jan-20)

JKT0368A (Exp Jan-20)

JKT0370A (Exp Jan-20)

JKT0371A (Exp Feb-20)

JKT0515A (Exp Feb-20)

JKT0514A (Exp Feb-20)

JKT0516A (Exp Feb-20)

JKT0518A (Exp Feb-20)

JKT0517A (Exp Feb-20)

JKT0694A (Exp Feb-20)

JKT0695A (Exp Feb-20)

JKT0696A (Exp Feb-20)

JKT0697A (Exp Mar-20)

JKT0698A (Exp Mar-20)

JKT1063A (Exp Mar-20)

JKT1064A (Exp Mar-20)

JKT1065A (Exp Mar-20)

JKT1148A (Exp Mar-20)

JKT1068A (Exp Mar-20)

JKT1146A (Exp Mar-20)

JKT1066A (Exp Mar-20)

JKT1149A (Exp Apr-20)

JKT1147A (Exp Apr-20)

JKT1150A (Exp Apr-20)

JKT1427A (Exp Apr-20)

JKT1428A (Exp Apr-20)

JKT1426A (Exp Apr-20)

JKT1429A (Exp Apr-20)

JKT1540A (Exp Apr-20)

JKT1539A (Exp Apr-20)

JKT1541A (Exp Apr-20)

JKT1543A (Exp Apr-20)

JKT1542A (Exp Apr-20)

JKT1725A (Exp May-20)

JKT1574A (Exp May-20)

JKT1727A (Exp May-20)

JKT1863A (Exp May-20)

JKT1864A (Exp May-20)

JKT1865A (Exp May-20)

JKT1726A (Exp May-20)

JKT2191A (Exp Jun-20)

JKT1866A (Exp Jul-20)

JKT2192A (Exp Jul-20)

JKT2193A (Exp Jul-20)

JKT2194A (Exp Jul-20)

Date Ranges: January 2020, February 2020, March 2020, April 2020, May 2020, June 2020, July 2020, August 2020, September 2020, October 2020, November 2020, December 2020, February 2021

Product: Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), 10 mL Multiple Dose Vial

Model:

NDC 62756-016-40

Recall #: D-0788-2020

Lot Numbers:

JKT1862A (Exp May-20)

JKT1578A (Exp May-20)

JKT2000A (Exp Jun-20)

JKT1999A (Exp Jun-20)

JKT2001A (Exp Jun-20)

JKT2593A (Exp Jul-20)

JKT2594A (Exp Jul-20)

JKT3863A (Exp Nov-20)

JKT4013A (Exp Nov-20)

JKU0037A (Exp Dec-20)

JKU0038A (Exp Dec-20)

JKU0358A (Exp Dec-20)

Date Ranges: May 2020, June 2020, July 2020, November 2020, December 2020