testosteronedrugHigh PriorityActive

Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet la

testosterone Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet la recalled by FDA. Defective Container - A defect in the side-seal which allows leakage of product.

By RecallRadar Editorial Team

Sourced from FDA. Last reviewed March 4, 2026.

This recall involves safety concerns. Take action promptly.

Plain-English Summary

testosterone Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet la recalled by FDA. Defective Container - A defect in the side-seal which allows leakage of product.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
November 7, 2025
Last reviewed by RecallRadar
March 4, 2026

What You Should Do

  1. 1## Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-
  2. 2Packet la Agency: FDA | Category: drug Reason: Defective Container - A defect in the side-seal which allows leakage of product. What to do:
  3. 3Stop using the product if your lot/model matches.
  4. 4Check the FDA notice for specifics.
Open Official Recall NoticeGet Alerts for testosterone Devices

What's Being Recalled

Quoted source excerpt from the official notice.

Defective Container - A defect in the side-seal which allows leakage of product.

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Lot #100068692, Exp.: 04/30/2027

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

Frequently Asked Questions

Is my testosterone device affected?

Check the affected models section on this page. The official notice currently lists Lot #100068692, Exp.: 04/30/2027.

What is the remedy for this recall?

## Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet la Agency: FDA | Category: drug Reason: Defective Container - A defect in the side-seal which allows leakage of product. What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: testosterone recall hub and Food & Drug recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

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Quick Info

Brand
testosterone
Category
drug
Source Agency
FDA
Announced
November 7, 2025
Country
US
Status
Active

Source & Verification

Sourced from FDA. Last reviewed March 4, 2026.

Official source
FDA
Announced by source
November 7, 2025
Last reviewed by RecallRadar
March 4, 2026

Official Resources

Use these primary sources for final eligibility and claim instructions.

Open Official Recall NoticeView official notice from FDA

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