Testosterone Cypionate Injectable Drug Recalled for Manufacturing Deviations
Sun Pharmaceutical is recalling 27 vials of Testosterone Cypionate Injection (200 mg/mL) due to manufacturing deviations caused by abnormal machinery appearance. The recall affects multiple lot numbers distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with manufacturing deviations and no reported illnesses or injuries. The hazard is a quality control issue without explicit patient harm reports, consistent with a precautionary manufacturing quality recall.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 27 vials of Testosterone Cypionate Injection, USP, 200 mg/mL (NDC 62756-015-40 and other package sizes). The affected lots are JKX3267A, JKX3686A, JKX4700A, and JKX5727A, with expiration dates ranging from August 2022 to November 2022. The product was distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Manufacturing deviations were reported that resulted from abnormal appearance on parts of machinery used in the manufacturing process.
Patients and healthcare providers who possess this medication are advised to consult their healthcare provider regarding the affected lot numbers. Patients should not discontinue use without medical guidance. Healthcare providers should verify the lot numbers on dispensed product and ensure that affected lots are not dispensed or used. Anyone with questions should contact their healthcare provider or the FDA.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- Affected units
- 27
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots JKX3267A & JKX3686A Exp. Date 08/2022 Lot JKX4700A
- Exp Date 10/2022 Lot JKX5727A
- Exp date 11/2022
UPCs (3)
- 0362756017405
- 0362756015401
- 0362756016408
Distribution
Distributed nationwide across the United States.
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