Testosterone Cypionate Injection (Sun Pharma) – Incorrect Labeling (2021)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
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 Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma Ind. Inc, NJ 08512 Manufactured by: Sun Pharma Ind. Ltd., India NDC 62756-015-40
Brand
SUN PHARMACEUTICAL INDUSTRIES INC
Lot Codes / Batch Numbers
Lot JKX2553A
Products Sold
Lot JKX2553A
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial due to Incorrect Labeling: Incorrect lot number on secondary packaging. 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
Incorrect Labeling: Incorrect lot number on secondary packaging
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