InvaGen Testosterone Topical Solution Recall: Defective Pump Actuator
InvaGen recalls Testosterone Topical Solution due to defective containers that may deliver incorrect doses. Check lot numbers GH80480 and GH80481.
Use caution until it’s fixed
Defective Container; actuator may improperly function and affect dose delivery.
Contact the company
What happened, in plain English
InvaGen Pharmaceuticals is recalling Testosterone Topical Solution because the pump actuator may not function properly, potentially affecting how much medication is delivered. The affected bottles were manufactured by Cipla Ltd for InvaGen and have expiration dates in March 2020. No remedy or return instructions are currently listed in the recall record. Read more at govinfonow.com/recall/38718-invagen-testosterone-topical-solution-recall-defective-pump-actuator.
Source Summary by GovInfoNow · govinfonow.com/recall/38718-invagen-testosterone-topical-solution-recall-defective-pump-actuator · Updated October 11, 2026 · FDA enforcement record: FDA #D-1454-2019
Cite this page
“InvaGen Testosterone Topical Solution Recall: Defective Pump Actuator.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/38718-invagen-testosterone-topical-solution-recall-defective-pump-actuator. 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's actuator is defective, which can cause it to improperly function. This defect may result in the delivery of an incorrect dose of testosterone per pump actuation, leading to under-dosing or over-dosing.
Who’s affected
Individuals who purchased Testosterone Topical Solution from nationwide distributors between the manufacturing date and June 12, 2019. Patients relying on precise testosterone dosing are most at risk of receiving an incorrect amount.
How to tell if you have this one
Check if you have Testosterone Topical Solution manufactured by InvaGen Pharmaceuticals (manufactured by Cipla Ltd). Look for NDC 69097-363-44 and lot numbers GH80480 or GH80481 with an expiration date of 3/2020.
- Brand
InvaGen Pharmaceuticals- Category
Drug
What to do — step by step
Check your product details
Verify if your bottle matches NDC 69097-363-44 and has lot numbers GH80480 or GH80481.
Monitor for remedy updates
The recall record does not currently list a specific remedy, return process, or refund instruction.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
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 qwen3.6:35b-a3b on October 11, 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.