Androgen, Anabolic Steroid Injection Recalled

Sun Pharmaceutical Industries Inc. is recalling dozens of lots of testosterone cypionate for injection that were manufactured under conditions similar to a previously rejected lot. The recall was published in the January 22, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

The recall spans the following products, which were distributed throughout the United States:

• testosterone cypionate for injection, 1000 mg/10 mL (100 mg/mL), 10-mL multiple-dose vials (NDC 62756-017-40) from lots JKT0933A, JKT0935A, and JKT1062A (Exp. 3/20); JKT1425A and JKT1483A (Exp. 4/20); JKT1575A, JKT1729A, JKT1730A, and JKT1728A (Exp. 5/20); JKT2002A (Exp. 6/20); JKT3216A and JKT3217A (Exp. 9/20); JKT3589A, JKT3590A, and JKT3626A (Exp 10/20); and JKT3864A and JKT3935A (Exp. 12/20);
• testosterone cypionate for injection, 2000 mg/10 mL (200 mg/mL), 1-mL single-use vials (NDC 62756-015-40) from lots JKT0075A, JKT0076A, JKT0213A, JKT0215A, JKT0369A, JKT0214A, JKT0368A, and JKT0370A (Exp. 1/20); JKT0371A, JKT0515A, JKT0514A, JKT0516A, JKT0518A, JKT0517A, JKT0694A, JKT0695A, and JKT0696A (Exp. 2/20); JKT0697A, JKT0698A, JKT1063A, JKT1064A, JKT1065A, JKT1148A, JKT1068A, JKT1146A, and JKT1066A (Exp. 3/20); JKT1149A, JKT1147A, JKT1150A, JKT1427A, JKT1428A, JKT1426A, JKT1429A, JKT1540A, JKT1539A, JKT1541A, JKT1543A, and JKT1542A (Exp. 4/20); JKT1725A, JKT1574A, JKT1727A, JKT1863A, JKT1864A, JKT1865A, and JKT1726A (Exp. 5/20); JKT2191A (Exp. 6/20); JKT1866A, JKT2192A, JKT2193A, JKT2194A, JKT2575A, JKT2195A, and JKT2576A (Exp. 7/20); JKT2578A, JKT2579A, JKT2911A, JKT2907A, JKT2908A, JKT2909A, JKT2910A, and JKT2577A (Exp. 8/20); JKT3104A, JKT3105A, JKT3106A, JKT3260A, JKT3261A, JKT3263A, JKT3107A, JKT3467A, JKT3262A, and JKT3264A (Exp. 9/20); JKT3788A, JKT3468A, JKT3749A, JKT3469A, and JKT3787A (Exp. 10/20); JKT3790A, JKT4019A, JKT3789A, JKT4016A, JKT4014A, and JKT4017A (Exp. 11/20); JKU0040A (Exp. 12/20); and JKU0041A, JKU0042A, JKU1043A, and JKU1044A (Exp. 2/21); and
• testosterone cypionate for injection, 2000 mg/10 mL (200 mg/mL), 10-mL multiple-dose vials (NDC 62756-016-40) from lots JKT1862A and JKT1578A (Exp. 5/20); JKT2000A, JKT1999A, and JKT2001A (Exp. 6/20); JKT2593A and JKT2594A (Exp. 7/20); JKT3863A and JKT4013A (Exp. 11/20); and JKU0037A, JKU0038A, and JKU0358A (Exp. 12/20).

Sun Pharmaceutical Industries initiated the recall January 14, 2020. Two days later, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Testosterone cypionate for injection is a prescription androgen and anabolic steroid medication used to treat hypogonadism in male patients and to treat certain types of breast cancer in women.

—Jolynn Tumolo