CLASS III Drug recall · Reported 25 Nov 2020 · FDA Enforcement Report
Testosterone Gel 1% per unit dose recalled by Teva Pharmaceuticals U
Teva Pharmaceuticals USA is recalling Testosterone Gel 1% per unit dose, distributed nationwide in the US. The recall was initiated on 11 Nov 2020 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-0100-2021
- FDA event ID
- 86738
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Testosterone
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Nov 2020
- FDA classified
- 20 Nov 2020
- Reported
- 25 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 11 Nov 2020 | Recall initiated by company | |
| 20 Nov 2020 | Classified by FDA | +9 days |
| 25 Nov 2020 | Published in enforcement report | +5 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: High out-of-specification assay results were 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%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.
Where it was distributed
Product was distributed Nationwide in the USA.
Questions about this recall
Why was it recalled?
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Which lots are affected?
Lot Number: 1351104, Exp 08/2021
Where was it sold?
Product was distributed 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 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 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 |