Testosterone Topical Solution 30mg of testosterone per pump actuation… — Class III drug recall D-1454-2019
Terminated recall by InvaGen Pharmaceuticals, Inc., reported 2019-07-10, distributed nationwide. Defective Container; actuator may improperly function and affect dose delivery.
| Recall number | D-1454-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | InvaGen Pharmaceuticals, Inc., Central Islip, NY, United States |
| Recall initiated | 2019-06-12 |
| Classified | 2019-07-03 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2021-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 1,776 bottles |
| Reason classes | packaging |
| NDC | 69097-0363, 69097-0363-44 |
| Lot numbers | GH80480, GH80481 |
| Expiration dates | 2020-03 |
Product
Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44
Reason for recall
Defective Container; actuator may improperly function and affect dose delivery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1454-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.