Class II · Moderate risk
Testosterone 100mg Anastrozole 4mg
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone Gel 1%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of foreign substance: Presence of Benzene.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02
Affected NDC
64380-0151-02
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 64380-0151 |
25 mg/2.5g | Gel Transdermal |
Strides Pharma Science Limited | Rx · CIII |
- Recalling firm
- Strides Pharma, Inc.
- NDC code
- 64380-151-02
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0293-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Testosterone recalls
See all
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
Other recalls by Strides Pharma, Inc.
All 2025 recalls
Class II · Moderate risk
Children's Ibuprofen Oral Suspension
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Class II · Moderate risk
Cinacalcet Tablets 90 mg
Failed Dissolution Specifications.
Class II · Moderate risk
Testosterone Gel 1%
Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk
Methoxsalen Capsules
Failed Dissolution Specifications
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