CLASS III ONGOING Drug recall · Reported 10 Dec 2025 · FDA Enforcement Report
Carton label: Testosterone Gel 1% per unit dose, Ciii-dose packets recalled
Teva Pharmaceuticals USA is recalling Carton label: Testosterone Gel 1% per unit dose, Ciii-dose packets, distributed nationwide in the US. The recall was initiated on 7 Nov 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0198-2026
- FDA event ID
- 97944
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Testosterone
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 7 Nov 2025
- FDA classified
- 1 Dec 2025
- Reported
- 10 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 7 Nov 2025 | Recall initiated by company | |
| 1 Dec 2025 | Classified by FDA | +24 days |
| 10 Dec 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container - A defect in the side-seal which allows leakage of product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Carton label: Testosterone Gel 1% per unit dose, Ciii-dose packets recalled?
Yes. Teva Pharmaceuticals USA recalled Carton label: Testosterone Gel 1% per unit dose, Ciii-dose packets on 7 Nov 2025. The recall is Class III and its status is Ongoing. Recall number D-0198-2026.
Why was it recalled?
Defective Container - A defect in the side-seal which allows leakage of product.
Which lots are affected?
Lot #100068692, Exp.: 04/30/2027
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teva Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
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| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Testosterone recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Gel 1%-dose packets recalled by Strides PharmaTestosterone | Strides Pharma | Benzene | Nationwide |
| Drug | CLASS II | Testosterone Gel 1%-dose Packets recalled by Strides PharmaTestosterone | Strides Pharma | Benzene | Nationwide |
| Drug | CLASS II | Testosterone Gel, 62%, (Alcohol 80% v/v)-dose packets recalledTestosterone | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Testosterone Gel, 62% CIII (Alcohol 80% v/v) recalledTestosterone | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Testosterone Gel 1% (25mg testosterone/ of gel) per unit dose recalledTestosterone | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |