US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 12, 2018 (8 years ago)

Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by…

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

Why it was recalled

Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.

What was recalled

Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40

Recalling firm
Sun Pharmaceutical Industries, Inc.
NDC code
62756-016-40
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0977-2018

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.

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