Testosterone Cypionate for Injection

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

Why it was recalled

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

Cause type: Failed specification

A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.

What was recalled

Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India

Affected NDCs 62756-0015-40 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 codes this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Testosterone Cypionate NDC 62756-0015	200 mg/mL	Injection, Solution Intramuscular	Sun Pharmaceutical Industries, Inc.	Rx · CIII
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: 62756-015-40
Origin: NJ, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0788-2020 · 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.