Lower riskDrug recall · FDA · Published November 7, 2025
Teva Testosterone Gel 1% Risk of Leakage - Recall Notice
Teva Pharmaceuticals recalls Testosterone Gel 1% (2.5g doses) due to defective container causing leakage. This may lead to product contamination. Affected units have specific lot numbers and expiration dates.
“Teva Testosterone Gel 1% Risk of Leakage - Recall Notice.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31642-teva-testosterone-gel-1-risk-of-leakage-recall-notice. Based on FDA recall #D-0198-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0198-2026%22&limit=1).
The FDA announced on Nov. 7, 2025, that Teva Pharmaceuticals USA, Inc. is recalling Testosterone Gel 1% due to a defective container side-seal that allows product leakage. The voluntary Class III recall affects approximately 15,944 cartons distributed nationwide.
How to tell if you have it
Brand: Teva Pharmaceuticals
Product: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only
Manufacturer: Actavis Laboratories, Inc
Distributor: Actavis Pharma, Inc.
NDC: 0591-3216-30 (Carton), 0591-3216-17 (Packet)
Lot #: 100068692
Expiration: 04/30/2027
The hazard
The recall is due to a defect in the side-seal of the unit-dose packets which allows leakage of the product. The FDA classifies this as a Class III recall.
Context
GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has 59 other recalls on record since April 2, 2012. Recent Teva recalls include traZODone 50mg tablets with foreign tablets risk (Aug. 24, 2026), Octreotide Acetate 30mg Kit sterility risk (April 24, 2026), and Claravis 10mg impurity issues (April 6, 2026). Other recent recalls of similar products include PureLife Benzoic Anesthetic Gel Recall (May 21, 2026), Keystone Safco SensiCaine-Ultra Gel Recall (May 21, 2026), and Keystone Pearson Topical Anesthetic Gel Recall (May 21, 2026).
How to tell if you have this one
Check for the lot number #100068692 on the carton. The product expires April 30, 2027. The product is sold in 30-unit-dose packets with NDC 0591-3216-30.
Brand
Teva Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the lot number #100068692 on the carton or the NDC code 0591-3216-30.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0198-2026 (November 7, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0198-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.