Testosterone Cypionate Injection (Sun Pharmaceutical) – Manufacturing Deviation (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India
Brand
Sun Pharmaceutical Industries, Inc.
Lot Codes / Batch Numbers
JKT0933A, JKT0935A, JKT1062A exp Mar-20, JKT1425A, JKT1483A exp Apr-20, JKT1575A, JKT1729A, JKT1730A, JKT1728A exp May-20 JKT2002A exp Jun-20, JKT3216A, JKT3217A exp Sep-20, JKT3589A, JKT3590A, JKT3626A exp Oct-20, JKT3864A, JKT3935A exp Dec-20
Products Sold
JKT0933A, JKT0935A, JKT1062A exp Mar-20; JKT1425A, JKT1483A exp Apr-20; JKT1575A, JKT1729A, JKT1730A, JKT1728A exp May-20 JKT2002A exp Jun-20; JKT3216A, JKT3217A exp Sep-20; JKT3589A, JKT3590A, JKT3626A exp Oct-20; JKT3864A, JKT3935A exp Dec-20
Sun Pharmaceutical Industries, Inc. is recalling Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC due to cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026