CLASS II Drug recall · Reported 17 Nov 2021 · FDA Enforcement Report
Testosterone Cypionate 200mg/ML Inj # Ethyl Oleate Injectable recalled
Vita Pharmacy is recalling Testosterone Cypionate 200mg/ML Inj # Ethyl Oleate Injectable, distributed in District of Columbia, Puerto Rico. The recall was initiated on 12 Oct 2021 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-0179-2022
- FDA event ID
- 88862
- Recalling firm
- Vita Pharmacy, San Antonio, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Oct 2021
- FDA classified
- 8 Nov 2021
- Reported
- 17 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Oct 2021 | Recall initiated by company | |
| 8 Nov 2021 | Classified by FDA | +27 days |
| 17 Nov 2021 | Published in enforcement report | +9 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 200MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Where it was distributed
United States including Washington, D.C. and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of assurance of sterility
Which lots are affected?
Lot: T1007302021:72 BUD: 01/26/2022; T1005182021:09 BUD: 11/15/2021; T1008112021:73 BUD: 02/07/2022; T1004092021:40 BUD: 10/09/2021; T1006182021:37 BUD: 12/15/2021; T1005242021:71 BUD: 11/20/2021; T1006072021:06 BUD: 12/04/2021; T0606222021:35 BUD: 12/19/2021; T0605112021:23 BUD:11/07/2021 ; T0608162021:19 BUD: 02/12/2022; T1009132021:25 BUD: 03/12/2022; T1004272021:41 BUD: 10/24/2021; T0604152021:26 BUD: 10/12/2021; T1006302021:53 BUD: 12/27/2021; T1008022021:01 BUD: 01/29/2022; T1008302021:73 BUD: 02/26/2022; T1008052021:84 BUD: 02/01/2022; T1007152021:72 BUD: 01/11/2022; T1005112021:54 BUD: 11/07/2021; T1008042021:66 BUD: 01/31/2022; T1007062021:95 BUD: 01/02/2022; T1008302021:73 BUD: 02/26/2022; T1008052021:84 BUD: 02/01/2022; T1007152021:72 BUD: 01/11/2022; T1005112021:54 BUD: 11/07/2021; T1006142021:21 BUD: 12/11/2021; T1008042021:66 BUD: 01/31/2022; T1005102021:94 BUD: 11/06/2021; T1007282021:89 BUD: 01/24/2022; T1009222021:75 BUD: 03/21/2022; T1005052021:79 BUD: 11/01/2021; T1008192021:65 BUD: 02/15/2022; T1007132021:14 BUD: 01/09/2022; T1008162021:35 BUD: 02/12/2022; T0607282021:28 BUD: 01/24/2022; T1006022021:06 BUD: 11/29/2021; T1006222021:31 BUD: 12/19/2021; T1004292021:70 BUD: 10/26/2021; T1007212021:82 BUD: 01/17/2022; T1006282021:88 BUD: 12/25/2021; T1004222021:18 BUD: 10/19/2021; T1009082021:11 BUD: 03/07/2022; T1007082021:50 BUD: 01/04/2022; T1009212021:76 BUD: 03/20/2022; T1008312021:01 BUD: 02/27/2022; T0507062021:21 BUD: 01/02/2022; T1004152021:11 BUD: 10/12/2021; T1004192021:50 BUD: 10/16/2021; T1005132021:31 BUD: 11/09/2021; T1008252021:57 BUD: 02/21/2022; T1009152021:06 BUD: 03/14/2022; T1007232021:57 BUD: 01/19/2022; T1006162021:17 BUD: 12/13/2021; T1007122021:16 BUD: 01/08/2022; T1006102021:50 BUD: 12/07/2021; T1005282021:72 BUD: 11/24/2021; T0209082021:89 BUD: 03/08/2022; T0106092021:28 BUD: 11/07/2021; T0205112021:63 BUD: 11/07/2021; T0604152021:26 BUD: 10/12/2021; T0106092021:53 BUD: 11/07/2021; T0205112021:63 BUD: 11/07/2021; T0209092021:89 BUD: 03/08/2022; T0109032021:43 BUD: 11/07/2021
Where was it sold?
United States including Washington, D.C. and Puerto Rico
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
100 other products · FDA event 88862This product is part of a recall event; the main page for the event is B Complex Inj Cmp-no B12, No Lidocaine Injectable recalled.
More recalls from Vita Pharmacy
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|---|---|---|---|---|---|
| Drug | CLASS II | Tri-mix Papaverine 30/phentolamine 2/pge-1 30 Inj Injectable recalled | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Alprostadil 25mcg/ML 25mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Testosterone Bi-blend 100/100mg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Alprostadil 32mcg/ML 32mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Alprostadil 30mcg/ML Inj 30mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |
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 |