Testosterone Cypionate Injection

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.

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

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

Affected NDC 62756-0016-40

Compare with the code on your package — it is the most precise check available.

Drug: Testosterone

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Testosterone Cypionate NDC 62756-0016	200 mg/mL	Injection, Solution Intramuscular	Sun Pharmaceutical Industries, Inc.	Rx · CIII

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 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.