FDA Recalls Testosterone Injectable Due to Sterility Assurance Concerns
Beacon Hill Medical Pharmacy is recalling Testosterone Hypoallergenic and Testosterone Aqueous injectables due to FDA inspectional findings regarding sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. Per the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4; however, FDA Class II with significant quality control failures impacting sterility assurance in injectable drugs warrants a score of 4 (Severe) due to the high risk of serious injury from non-sterile administration.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling Testosterone Hypoallergenic 200 mg/mL Injectable and Testosterone Aqueous 100 mg/mL Injectable. The products are compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, MI, and are distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. The agency has classified this recall as Class II.
Patients who have received these products should contact their healthcare provider for guidance. The specific lot codes associated with this recall are 03112013@9, 05242013@17, 05312013@7, and 06052013@21.
The recalled product
- Product
- TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Manufacturer
- Beacon Hill Medical Pharmacy, P.C.
- Category
- Drug — Injectable
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 (4)
- 03112013@9
- 05242013@17
- 05312013@7
- 06052013@21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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 86 products in this recall →Related recalls
Same manufacturer · Beacon Hill Medical Pharmacy, P.C.
See all →- SevereBeacon Hill Medical Pharmacy Recalls B-12 Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- HighBeacon Hill Medical Pharmacy Recalls Sermorelin Acetate Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- SevereBeacon Hill Medical Pharmacy Recalls Potassium Chloride Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- SevereBeacon Hill Medical Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- SevereBeacon Hill Medical Pharmacy Recalls Multitrace-5 Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29