Class II · Moderate risk
Testosterone 100mg Anastrozole 4mg
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone Gel 1%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
Affected NDCs
0591-3216-17
0591-3216-30
Compare with the code on your package — it is the most precise check available.
Drug: Testosterone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Testosterone NDC 00591-3216 |
10 mg/g | Gel Topical |
Actavis Pharma, Inc. | Rx · CIII |
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0591-3216-17
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0100-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Testosterone recalls
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Class II · Moderate risk
Testosterone 87.5mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 200mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 75mg
Presence of Foreign substance - potential presence of metal particulate matter
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