FDA Drug recall D-1642-2015

Testosterone Cypionate 200mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

FDA Drug
Class II
terminated
Published 2015-09-23

On 2015-09-23 the FDA classified a Class II recall of Testosterone Cypionate 200mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN by The Compounding Pharmacy, citing lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1642-2015
Classification	Class II
Status	terminated
Initiated	2015-06-02
Published	2015-09-23
Last updated	2026-09-13 11:51 UTC
Company	The Compounding Pharmacy
Distribution	US

Product

Testosterone Cypionate 200mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Reason

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Identifiers

code_info	All lots distributed between November 2014 and May 2015; 01142015@3, 7/13/2015; 01142015@13, 7/13/2015; 03032015@47,… All lots distributed between November 2014 and May 2015; 01142015@3, 7/13/2015; 01142015@13, 7/13/2015; 03032015@47, 8/30/2015; 05042015@33, 10/31/2015; 11242014@30, 5/23/2015; 11242014@34, 5/23/2015; 12182014@79, 6/16/2015; 12232014@4, 6/21/2015; 01232015@28, 7/22/2015; 01142015@17, 7/13/2015; 01302015@6, 7/29/2015; 02022015@5, 8/1/2015; 04092015@10, 10/6/2015; 02162015@4, 8/15/2015; 02192015@19, 8/18/2015; 03032015@48, 8/30/2015; 03202015@100, 9/16/2015; 03202015@11, 9/16/2015; 04132015@18, 10/10/2015; 04202015@14, 10/17/2015; 03302015@12, 9/26/2015; 04062015@23, 10/3/2015; 04082015@10, 10/5/2015; 04242015@1, 10/21/2015; 04292015@29, 10/26/2015; 12012014@23, 5/30/2015; 03042015@50, 8/31/2015; 03262015@56, 9/22/2015; 04062015@21, 10/3/2015; 05012015@51, 10/28/2015; 11242014@8, 5/23/2015; 05052015@23, 11/1/2015; 12042014@54, 6/2/2015; 04102015@21, 10/7/2015; 01122015@41, 7/11/2015; 12162014@3, 6/14/2015; 12012014@28, 5/30/2015; 12052014@17, 6/3/2015; 12172014@34, 6/15/2015; 12192014

code_info

All lots distributed between November 2014 and May 2015; 01142015@3, 7/13/2015; 01142015@13, 7/13/2015; 03032015@47,…

All lots distributed between November 2014 and May 2015; 01142015@3, 7/13/2015; 01142015@13, 7/13/2015; 03032015@47, 8/30/2015; 05042015@33, 10/31/2015; 11242014@30, 5/23/2015; 11242014@34, 5/23/2015; 12182014@79, 6/16/2015; 12232014@4, 6/21/2015; 01232015@28, 7/22/2015; 01142015@17, 7/13/2015; 01302015@6, 7/29/2015; 02022015@5, 8/1/2015; 04092015@10, 10/6/2015; 02162015@4, 8/15/2015; 02192015@19, 8/18/2015; 03032015@48, 8/30/2015; 03202015@100, 9/16/2015; 03202015@11, 9/16/2015; 04132015@18, 10/10/2015; 04202015@14, 10/17/2015; 03302015@12, 9/26/2015; 04062015@23, 10/3/2015; 04082015@10, 10/5/2015; 04242015@1, 10/21/2015; 04292015@29, 10/26/2015; 12012014@23, 5/30/2015; 03042015@50, 8/31/2015; 03262015@56, 9/22/2015; 04062015@21, 10/3/2015; 05012015@51, 10/28/2015; 11242014@8, 5/23/2015; 05052015@23, 11/1/2015; 12042014@54, 6/2/2015; 04102015@21, 10/7/2015; 01122015@41, 7/11/2015; 12162014@3, 6/14/2015; 12012014@28, 5/30/2015; 12052014@17, 6/3/2015; 12172014@34, 6/15/2015; 12192014

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1642-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.