Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Testosterone Gel 1% Recalled for Being Superpotent

Agency Publication Date: November 17, 2020

Summary

Teva Pharmaceuticals USA is recalling 12,088 cartons of Testosterone Gel 1% (2.5 grams per unit dose) because the medication was found to be superpotent during stability testing. This means the gel contains a higher level of testosterone than specified, which was discovered through out-of-specification assay results. The affected product includes 30 unit-dose packets per carton and was distributed nationwide across the United States.

Risk

Using a superpotent drug may result in consumers receiving a higher dose of testosterone than intended. This could lead to an increased risk of adverse health effects or unexpected side effects associated with excessive testosterone exposure.

What You Should Do

Check your medication packaging to see if you have Testosterone Gel 1%, 2.5 grams per unit dose, in 30-count cartons.
Look for lot number 1351104 with an expiration date of 08/2021 on the carton or individual packets.
Verify the NDC numbers: the individual 2.5 gram packets are labeled NDC 0591-3216-17, and the 30-count cartons are labeled NDC 0591-3216-30.
Contact your healthcare provider or pharmacist immediately for guidance if you have been using the affected medication.
Return any unused product from this specific lot to your pharmacy for a refund and contact the manufacturer, Teva Pharmaceuticals USA, for further instructions.
For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

How to: Consumers should stop using the affected lot and return it to the place of purchase.

Affected Products

Product: Testosterone Gel 1%, 2.5 grams per unit dose (30 Unit-Dose Packets per carton)

Model:

NDC 0591-3216-17

NDC 0591-3216-30

Lot Numbers:

1351104 (Exp 08/2021)

Date Ranges: Exp 08/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86738

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Manufactured In: United States

Units Affected: 12,088 cartons

Distributed To: Nationwide

Agency Last Updated: November 20, 2020

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 to see if you have Testosterone Gel 1%, 2.5 grams per unit dose, in 30-count cartons.

Look for lot number 1351104 with an expiration date of 08/2021 on the carton or individual packets.

Verify the NDC numbers: the individual 2.5 gram packets are labeled NDC 0591-3216-17, and the 30-count cartons are labeled NDC 0591-3216-30.

Contact your healthcare provider or pharmacist immediately for guidance if you have been using the affected medication.

Return any unused product from this specific lot to your pharmacy for a refund and contact the manufacturer, Teva Pharmaceuticals USA, for further instructions.

For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.