Testosterone USP 99 — Class II drug recall D-0387-2016
Terminated recall by Qualgen, reported 2015-12-02, distributed nationwide. Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient
| Recall number | D-0387-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualgen, Edmond, OK, United States |
| Recall initiated | 2015-10-09 |
| Classified | 2015-11-24 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2017-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 10,885 vials |
| Reason classes | sterility |
| NDC | 69761-0110-01, 69761-0120-01, 69761-0125-01, 69761-0137-01, 69761-0150-01, 69761-0187-01 |
| Lot numbers | A005, A008, A010, A012, A015, A018, A022, A024, A026, A029, A033, A038, A040, A041, A045, A046, A047, A052, A055, A058, A059, A061 |
Product
Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013
Reason for recall
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
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-0387-2016. 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.