CLASS II Drug recall · Reported 3 Aug 2022 · FDA Enforcement Report
Testosterone Gel 1% (25mg testosterone/ of gel) per unit dose recalled
Teva Pharmaceuticals USA is recalling Testosterone Gel 1% (25mg testosterone/ of gel) per unit dose, distributed nationwide in the US. The recall was initiated on 29 Jun 2022 and the FDA has classified it as Class II.
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-1289-2022
- FDA event ID
- 90534
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Testosterone
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2022
- FDA classified
- 25 Jul 2022
- Reported
- 3 Aug 2022
- Type
- Voluntary: Firm initiated
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 29 Jun 2022 | Recall initiated by company | |
| 25 Jul 2022 | Classified by FDA | +26 days |
| 3 Aug 2022 | 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
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Which lots are affected?
Lot: 1403180, EXP. 10/2022
Where was it sold?
Nationwide in the USA
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 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
All 281| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets recalledMetoclopramide | Teva Pharmaceuticals USA | Other | Nationwide |
| 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 |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Testosterone recalls
All 91| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone, 37.5 mg, 1 Sterile Pellet recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone, 50.0 mg, 1 Sterile Pellet recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone, 18.0 mg, 1 Sterile Pellet recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |