Testosterone Cypionate Injection — Class II drug recall D-1124-2019
Terminated recall by InvaGen Pharmaceuticals, Inc., reported 2019-04-24, distributed nationwide. Presence of Particulate Matter.
| Recall number | D-1124-2019 |
|---|---|
| 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 | 692,538 vials |
| Reason classes | specification failure |
| NDC | 69097-0536, 69097-0536-37, 69097-0537, 69097-0537-31, 69097-0537-37 |
| Lot numbers | GH80009, GH80010, GH80011, GH80568, GH80575, GH80579, GH80580, GH80581, GH80582, GH80646, GH80664, GH80665, GH80684, GH80699, GH80700, GH80701, GH80746, GH80761, GH80765, GH80777, GH80801, GH80823, GH80828, GH80878, GH80967, GH80968, GH81033, GH81034, GH81042, GH81154, GH81255, GH81256, GH81288, GH81289, GH81310, GH81311 |
| Expiration dates | 2019-12, 2020-04, 2020-05, 2020-06, 2020-07, 2020-08, 2020-10 |
Product
Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single 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 69097-537-31.
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-1124-2019. 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.