US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 15, 2023 (4 years ago)

Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

What was recalled

Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.

Recalling firm
Azurity Pharmaceuticals, Inc.
NDC code
52536-625-10
Origin
MA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0489-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Testosterone recalls

See all