FDA Recall Testosterone Cypionate
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on June 21st, 2022 and classified as a Class II recall due to cgmp - water leakage This recall is currently terminated, and the associated recall number is recall number is D-1190-2022. It pertains to Testosterone Cypionate identified by 62756-016 as of 05-23-2023 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-1190-2022 | 06-21-2022 | 07-20-2022 | 50860 vials | Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol- Baroda Highway, Halol-Baroda, Highway, Halol- 389 350, Gujarat, India, NDC 62756-015-40. | cGMP - Water leakage | Terminated |
| D-1176-2022 | 06-03-2022 | 07-13-2022 | 27 vials | Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40. | CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery. | Terminated |
| D-1154-2022 | 06-10-2022 | 06-29-2022 | 47,500 vials | Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40. | Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion | Terminated |
| D-1153-2022 | 06-03-2022 | 06-29-2022 | 97,450 vials | Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40. | CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities. | Terminated |
| D-0242-2021 | 01-11-2021 | 02-03-2021 | 36,275 cartons | 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 | Incorrect Labeling: Incorrect lot number on secondary packaging | Terminated |
| D-0788-2020 | 01-14-2020 | 01-22-2020 | 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 | cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot. | Terminated | |
| D-0787-2020 | 01-14-2020 | 01-22-2020 | 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 | cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot. | Terminated | |
| D-0977-2018 | 07-12-2018 | 08-01-2018 | 5215 units | Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40 | Presence of Particulate Matter: organic and inorganic compounds detected in vials of product. | Terminated |
| D-0611-2017 | 03-15-2017 | 03-29-2017 | 83,188 single does vials | Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma Ind. Inc., NJ 08512, Manufactured by Sun Pharma Ind. Ltd. India, NDC 62756-015-40 | Presence of Particulate Matter | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
