Class III U.S. Food and Drug Administration

Teva Pharmaceuticals USA, Inc Carton label: Testosterone Gel 1% recall: Defective Container - A defect in the side-seal which allows leakage

Recall published 11 months ago

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

The hazard: Drug safety concern

This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

What the notice says: Defective Container - A defect in the side-seal which allows leakage of product.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0198-2026
Published
December 10, 2025
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Teva Pharmaceuticals USA, Inc
Product type
Prescription & OTC drugs
Units affected
15,944 cartons
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #100068692, Exp.: 04/30/2027

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

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 100068692

NDC number

On the carton and again on the bottle or blister label.

  • 0591-3216-30
  • 0591-3216-17

Package size

Match the net weight or the piece count on the front of the pack.

  • 2.5 grams

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Teva Pharmaceuticals USA, Inc — This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

  1. Check the lot number on your pack against the codes listed above.
  2. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  3. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  4. Keep the carton; the lot number is often printed only on the outer pack.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Teva Pharmaceuticals USA, Inc — 400 Interpace Pkwy Bldg A, Parsippany, NJ, 07054-1120

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Teva Pharmaceuticals USA, Inc prescription & otc drugs recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 100068692. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls