The Recall Registry
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Food & drug recall · FDANovember 7, 2025Labelling issue

Teva Pharmaceuticals USA, Inc — Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

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

The Recall Registry rates this labelling issue — FDA Class III: unlikely to cause harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Teva Pharmaceuticals USA, Inc

The product

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 label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.

Details

Units affected
15,944 cartons
Recall date
November 7, 2025
Brand
Teva Pharmaceuticals USA, Inc
Model, lot or SKU numbers
Lot #100068692, Exp.: 04/30/2027
Where it was distributed

U.S. Nationwide

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: “Teva Pharmaceuticals USA, Inc — 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., Par”

Read it on FDA →

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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