InvaGen Pharmaceuticals, Inc. recalls Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution
InvaGen Pharmaceuticals recalls Testosterone Topical Solution 30mg per pump due to defective container that may affect dose delivery. Affected units have NDC 69097-363-44, lots GH80480/80481.
Lower-risk recall
Defective Container; actuator may improperly function and affect dose delivery.
Contact the company & request your remedy
What happened, in plain English
InvaGen Pharmaceuticals is recalling Testosterone Topical Solution 30mg per pump because the container may not function properly, leading to incorrect dose delivery. This could affect how much testosterone a user receives with each pump. Read more at govinfonow.com/recall/38718-invagen-testosterone-topical-solution-recall-defective-container-may-affect-dose.
Source Summary by GovInfoNow · govinfonow.com/recall/38718-invagen-testosterone-topical-solution-recall-defective-container-may-affect-dose · Updated October 5, 2026 · FDA enforcement record: FDA #D-1454-2019
Cite this page
“InvaGen Testosterone Topical Solution Recall: Defective Container May Affect Dose Delivery.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38718-invagen-testosterone-topical-solution-recall-defective-container-may-affect-dose. Based on FDA recall #D-1454-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1454-2019%22&limit=1).
Why it’s dangerous
The container may not function correctly, which could mean each pump delivers too much or too little testosterone. This might lead to incorrect hormone levels in the body.
Who’s affected
People who own or use the recalled Testosterone Topical Solution 30mg per pump are affected. Men using this product for hormone replacement therapy are most at risk.
How to tell if you have this one
Check for the product name 'Testosterone Topical Solution 30mg per pump' with NDC code 690:97-363-44 and lots GH80480 or GH80481. The product was manufactured in India and sold in the US.
- Brand
InvaGen- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 69097-363-44 and lots GH80480 or GH80481 on the product label.
Questions people ask
Is this product safe to use?
The recall states the container may affect dose delivery, but it does not say the product is unsafe. Users should check if they have the recalled units.
What should I do if I have this product?
The recall does not specify a remedy, so users should check if they have the recalled units and contact InvaGen if needed.
How can I tell if I have the recalled product?
Check for NDC code 69097-363-44 and lots GH80480 or GH80481 on the product label.
Contact InvaGen
We’ve drafted a message you can send InvaGen to request your refund or repair — edit it as you like.
Subject: Recall D-1454-2019 — InvaGen InvaGen Hello, I own a InvaGen that is covered by recall D-1454-2019 from InvaGen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1454-2019 (June 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1454-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.