Testosterone Cypionate Injection, Solution
FDA Recall NDC 62756-016
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 9 recorded enforcement report(s) associated with Testosterone Cypionate (NDC 62756-016). A significant event, classified as Class II, was initiated on Jun 21, 2022 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "cGMP - Water leakage"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP - Water leakage
Jun 21, 2022
Jul 20, 2022
50860 vials
Recall Profile & Regulatory Data
Event ID
90451
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
May 23, 2023
Product Description
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.
Batch or Lot Expiration Information
Lot# HAC4337A
Affected Packages Involved in this Recall
62756-017-40Product
62756-015-40Product
62756-016-40Product
Class II Terminated
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Jun 03, 2022
Jul 13, 2022
27 vials
Recall Profile & Regulatory Data
Event ID
90412
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide.
Termination Date
May 25, 2023
Product Description
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.
Batch or Lot Expiration Information
Lot# Lots JKX3267A & JKX3686A Exp. Date 08/2022 Lot JKX4700A, Exp Date 10/2022 Lot JKX5727A, Exp date 11/2022
Affected Packages Involved in this Recall
62756-017-40Product
62756-015-40Product
62756-016-40Product
Class II Terminated
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Jun 10, 2022
Jun 29, 2022
47,500 vials
Recall Profile & Regulatory Data
Event ID
90391
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jul 25, 2023
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot: HAC3427A, EXP Date: 08/2023
Affected Packages Involved in this Recall
62756-017-40Product
62756-015-40Product
62756-016-40Product
Class II Terminated
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.
Jun 03, 2022
Jun 29, 2022
97,450 vials
Recall Profile & Regulatory Data
Event ID
90361
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
May 24, 2023
Product Description
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.
Batch or Lot Expiration Information
Lot# HAC1974A, HAC1978A, Exp 06/2023
Affected Packages Involved in this Recall
62756-017-40Product
62756-015-40Product
62756-016-40Product
Class III Terminated
Incorrect Labeling: Incorrect lot number on secondary packaging
Jan 11, 2021
Feb 03, 2021
36,275 cartons
Recall Profile & Regulatory Data
Event ID
87168
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 02, 2021
Product Description
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
Batch or Lot Expiration Information
Lot# Lot JKX2553A
Affected Packages Involved in this Recall
62756-017-40Product
62756-015-40Product
62756-016-40Product
January 2020 Class II Recall: cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Recall Number
Class II Terminated
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Jan 14, 2020
Jan 22, 2020
N/A
Recall Profile & Regulatory Data
Event ID
84672
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States.
Termination Date
Aug 31, 2020
Product Description
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
Batch or Lot Expiration Information
Lot# a) JKT0075A, JKT0076A, JKT0213A, JKT0215A, JKT0369A, JKT0214A, JKT0368A, JKT0370A exp Jan-20; JKT0371A, JKT0515A, JKT0514A, JKT0516A, JKT0518A, JKT0517A, JKT0694A, JKT0695A, JKT0696A, exp Feb-20; JKT0697A, JKT0698A, JKT1063A, JKT1064A, JKT1065A, JKT1148A, JKT1068A, JKT1146A, JKT1066A exp Mar-20; JKT1149A, JKT1147A, JKT1150A, JKT1427A, JKT1428A, JKT1426A, JKT1429A, JKT1540A, JKT1539A, JKT1541A, JKT1543A, JKT1542A exp Apr-20; JKT1725A, JKT1574A, JKT1727A, JKT1863A, JKT1864A, JKT1865A, JKT1726A exp May-20; JKT2191A exp Jun-20; JKT1866A, JKT2192A, JKT2193A, JKT2194A, JKT2575A, JKT2195A, JKT2576A exp Jul-20; JKT2578A, JKT2579A, JKT2911A, JKT2907A, JKT2908A, JKT2909A, JKT2910A, JKT2577A exp Aug-20; JKT3104A, JKT3105A, JKT3106A, JKT3260A, JKT3261A, JKT3263A, JKT3107A, JKT3467A, JKT3262A, JKT3264A exp Sep-20; JKT3788A, JKT3468A, JKT3749A, JKT3469A, JKT3787A exp Oct-20; JKT3790A, JKT4019A, JKT3789A, JKT4016A, JKT4014A, JKT4017A, Nov-20; JKU0040A exp Dec-20; JKU0041A, JKU0042A, JKU1043A, JKU1044A exp Feb-21; b) JKT1862A, JKT1578A exp May-20; JKT2000A, JKT1999A, JKT2001A exp Jun-20; JKT2593A, JKT2594A exp Jul-20; JKT3863A, JKT4013A exp Nov-20; JKU0037A, JKU0038A, JKU0358A exp Dec-20
Affected Packages Involved in this Recall
62756-017-40Product
62756-015-40Product
62756-016-40Product
January 2020 Class II Recall: cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Recall Number
Class II Terminated
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Jan 14, 2020
Jan 22, 2020
N/A
Recall Profile & Regulatory Data
Event ID
84672
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States.
Termination Date
Aug 31, 2020
Product Description
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
62756-017-40Product
62756-015-40Product
62756-016-40Product
Class II Terminated
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Jul 12, 2018
Aug 01, 2018
5215 units
Recall Profile & Regulatory Data
Event ID
80485
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Mar 11, 2019
Product Description
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
Batch or Lot Expiration Information
Lot# : JKS0280A, Exp. 06/2019
Affected Packages Involved in this Recall
62756-017-40Product
62756-015-40Product
62756-016-40Product
Class II Terminated
Presence of Particulate Matter
Mar 15, 2017
Mar 29, 2017
83,188 single does vials
Recall Profile & Regulatory Data
Event ID
76742
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 23, 2018
Product Description
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
Batch or Lot Expiration Information
Lot# JKR0744A, JKR0745A, JKR0750A, JKR0795A; Exp. 09/18
Affected Packages Involved in this Recall
62756-017-40Product
62756-015-40Product
62756-016-40Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
