Testosterone Cypionate Injection (InvaGen) – Particulate Matter (2019)
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 Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-31.
Brand
InvaGen Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
Lot #:GH80009, GH80010, GH80011 Exp 12/2019, GH80568, GH80575, GH80579, GH80580, GH80581, GH80582 Exp 4/2020, GH80646, GH80664, GH80665, GH80684, GH80699, GH80700, GH80701, GH80746, GH80761, GH80765, GH80777 Exp 05/2020, GH80801, GH80823, GH80828, GH80878 Exp 06/2020, GH80967, GH80968, GH81033, GH81034 Exp 07/2020, GH81042, GH81154 Exp 08/2020, GH81255, GH81256, GH81288, GH81289, GH81310 Exp 10/2020 and GH81311 Exp 10/2020
Products Sold
Lot #:GH80009, GH80010, GH80011 Exp 12/2019; GH80568, GH80575, GH80579, GH80580, GH80581, GH80582 Exp 4/2020; GH80646, GH80664, GH80665, GH80684, GH80699, GH80700, GH80701, GH80746, GH80761, GH80765, GH80777 Exp 05/2020; GH80801, GH80823, GH80828, GH80878 Exp 06/2020; GH80967, GH80968, GH81033, GH81034 Exp 07/2020; GH81042, GH81154 Exp 08/2020; GH81255, GH81256, GH81288, GH81289, GH81310 Exp 10/2020 and GH81311 Exp 10/2020
InvaGen Pharmaceuticals, Inc. is recalling Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, due to Presence of Particulate Matter.. 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
Presence of Particulate Matter.
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