CLASS II Drug recall · Reported 11 Jan 2017 · FDA Enforcement Report
Testosterone Cypionate in Grapeseed Oil Injectable recalled
Wells Pharmacy Network is recalling Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) b) c) and d) vials, distributed nationwide in the US. The recall was initiated on 21 Sep 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0327-2017
- FDA event ID
- 75289
- Recalling firm
- Wells Pharmacy Network, Ocala, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Sep 2016
- FDA classified
- 4 Jan 2017
- Reported
- 11 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Sep 2016 | Recall initiated by company | |
| 4 Jan 2017 | Classified by FDA | +105 days |
| 11 Jan 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot codes: 03282016@16, 03302016@4, 04042016@10, 04262016@3, 05162016@2, 06032016@2, 07062016@10, 08262016@2 b) Known lot code: 04012016@4, 04182016@6, 04282016@7, 05022016@4, 06142016@19, 08102016@22. c) Known lot code: 04042016@7, 05022016@9, 05272016@2, 06272016@13, 07292016@8, 08192016@10 d) Known lot code: 03242016@12, 04082016@6, 04142016@2, 04192016@5, 04272016@4, 05092016@4, 05232016@17, 06122016@6, 06082016@2, 06142016@148, 06162016@9, 06172016@13, 06232016@78, 06282016@31, 07122016@20, 08012016@25, 08032016@12, 08042016@13.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
96 other products · FDA event 75289This product is part of a recall event; the main page for the event is Alprostadil 20 mcg/mL Injectable, a) and b) vials recalled.
More recalls from Wells Pharmacy Network
All 104| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alprostadil 40 mcg/mL Injectable vials recalled | Wells Pharmacy Network | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Enanthate in Grapeseed Oil Injectable recalled | Wells Pharmacy Network | Sterility | Nationwide |
| Drug | CLASS II | QUAD2 (Pap/Phen/Alpros/Atro) 9 mg/1 mg/10 mg/0.1 mg/mL recalled | Wells Pharmacy Network | Sterility | Nationwide |
| Drug | CLASS II | Trimix Injectable 30 mg/3 mg/60 mcg/mL, a), b) and c) vials recalled | Wells Pharmacy Network | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin Injectable (Dr. Hall Kit) recalled | Wells Pharmacy Network | Sterility | Nationwide |
Other Testosterone Cypionate recalls
All 130| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate Injection, 200 mg/mL, CIII recalled | Empower Clinic Services | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL recalledTestosterone Cypionate | Azurity Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Enanthate 100/100mg/ml, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |