CLASS II Drug recall · Reported 22 Jan 2020 · FDA Enforcement Report

Testosterone Cypionate for Injection, 2,000 mg/ (200 mg/mL) recalled

Sun Pharmaceutical Industries is recalling Testosterone Cypionate for Injection, 2,000 mg/ (200 mg/mL), a) Single Use vial (, distributed nationwide in the US. The recall was initiated on 14 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 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

NDC62756-015, 62756-017, 62756-016

UPC0362756017405, 0362756015401, 0362756016408

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0788-2020
FDA event ID: 84672
Recalling firm: Sun Pharmaceutical Industries, Cranbury, NJ
Brand: Testosterone Cypionate
Manufacturer: Sun Pharmaceutical Industries, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 14 Jan 2020
FDA classified: 16 Jan 2020
Reported: 22 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Injectable & IV Drugs

Timeline

14 Jan 2020	Recall initiated by company
16 Jan 2020	Classified by FDA	+2 days
22 Jan 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Product was distributed throughout the United States.

Nationwide

Questions about this recall

Is Testosterone Cypionate for Injection, 2,000 mg/ (200 mg/mL), a) Single Use vial ( recalled?

Yes. Sun Pharmaceutical Industries recalled Testosterone Cypionate for Injection, 2,000 mg/ (200 mg/mL), a) Single Use vial ( on 14 Jan 2020. The recall is Class II and its status is Terminated. Recall number D-0788-2020.

Why was it recalled?

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

Which lots are affected?

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

Where was it sold?

Product was distributed throughout the United States.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Testosterone Cypionate recalls

All 23

Reported	Class	Recall	Company	Reason	Where
21 May 2025Drug	CLASS II	Testosterone Cypionate Injection, 200 mg/mL, CIII recalled	Empower Clinic Services	Sterility	Nationwide
23 Apr 2025Drug	CLASS II	Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate	Eugia US	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Testosterone Cypionate Injection, USP, CIII, 200 mg/mL recalledTestosterone Cypionate	Azurity Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
20 Jul 2022Drug	CLASS II	Testosterone Cypionate Injection, USP, 200mg/mL, CIII recalledTestosterone Cypionate	Sun Pharmaceutical Industries	Manufacturing (CGMP) Deviations	Nationwide
13 Jul 2022Drug	CLASS II	Testosterone Cypionate Injection, USP, 200mg/ml recalledTestosterone Cypionate	Sun Pharmaceutical Industries	Manufacturing (CGMP) Deviations	Nationwide