Testosterone Pellets Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Testosterone 100 mg sterile pellets nationwide because FDA inspections found GMP violations affecting sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
The Compounding Pharmacy of America is recalling 1,222 units of Testosterone 100 mg, Sterile Pellet. The product was distributed nationwide between November 2014 and May 2015. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The recall covers all lots distributed during the specified period. The source text does not report any specific illnesses or injuries associated with the use of these pellets. The hazard is described as a lack of assurance of sterility due to the identified manufacturing violations.
Consumers who have purchased or received these specific testosterone pellets should stop using them and contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Steroids
- Affected units
- 1,222
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- All lots distributed between November 2014 and May 2015
- 01082015@1
- 7/7/2015
- 11212014@6
- 5/20/2015
- 11212014@8
- 1242014@51
- 5/23/2015
- 11262014@72
- 5/25/2015
- 01152015@29
- 7/14/2015
- 02112015@12
- 8/10/2015
- 12192014@6
- 6/17/2015
- 12012014@57
- 5/30/2015
- 12022014@33
- 5/31/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 382 products in this recall →Related recalls
Same manufacturer · The Compounding Pharmacy of America
See all →- CriticalFDA Recalls Non-Sterile HCG and Methylcobalamin Injection Vials
FDA (Drugs) · 2018-02-21
- SevereFDA Recalls Morphine and Ropivacaine Compounded Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereHydromorphone Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereMorphine and Bupivacaine Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereMethylcobalamin Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22