Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 203 vials of compounded Testosterone Cypionate/Anastrozole Injectable nationwide due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Wells Pharmacy Network LLC is voluntarily recalling 203 vials of Testosterone Cypionate/Anastrozole Injectable, 200 mg/1 mg/mL, 10 mL vial. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall is being conducted because of a lack of assurance of sterility.
The recall includes all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiry date. Specific known lot codes include 03242016@4, 04122016@1, 05102016@10, 06092016@4, 07062016@12, and 08152016@3.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Testosterone Cypionate/Anastrozole Injectable, 200 mg/1 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 203
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 (7)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 03242016@4
- 04122016@1
- 05102016@10
- 06092016@4
- 07062016@12
- 08152016@3.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 97 recalled by Wells Pharmacy Network LLC 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 97 products in this recall →Related recalls
Same manufacturer · Wells Pharmacy Network LLC
See all →- SevereWells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereWells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits
FDA (Drugs) · 2017-01-11
- SevereWells Pharmacy Recalls Compounded Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereWells Pharmacy Recalls Trimix with Atropine Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereWells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereFDA Recalls Compounded Injectable Testosterone and Anastrazole Vials for Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereTestosterone Cypionate Anastrozole Injectable Recalled for Sterility Concerns
FDA (Drugs) · 2021-11-17
- SevereTestosterone Cypionate Injectable Recalled Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereFDA Recalls Testosterone Cypionate and Anastrazole Injection Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereTestosterone Cypionate Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- High