Testosterone Cypionate Injection — Class II drug recall D-1123-2019
Terminated recall by InvaGen Pharmaceuticals, Inc., reported 2019-04-24, distributed nationwide. Presence of Particulate Matter.
| Recall number | D-1123-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | InvaGen Pharmaceuticals, Inc., Central Islip, NY, United States |
| Recall initiated | 2019-03-22 |
| Classified | 2019-04-15 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2022-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 12,234 vials |
| Reason classes | specification failure |
| NDC | 69097-0536, 69097-0536-37, 69097-0537, 69097-0537-31, 69097-0537-37 |
| Lot numbers | GH80159, GH80160, GH80161, GH80489, GH80490, GH80502, GH80503, GH80504, GH80557, GH80598, GH80601, GH80602, GH80845, GH80846, GH80855, GH80856, GH80857, GH80877, GH80903, GH80908, GH80931, GH81047 |
| Expiration dates | 2020-01, 2020-03, 2020-04, 2020-06, 2020-07, 2020-08 |
Product
Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-37.
Reason for recall
Presence of Particulate Matter.
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-1123-2019. 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.