CLASS III Drug recall · Reported 6 Nov 2019 · FDA Enforcement Report
Testosterone Cypionate Injection, USP, 2000 mg/ Vial, Single-Dose recalled
Arbor Pharmaceuticals is recalling Testosterone Cypionate Injection, USP, 2000 mg/ Vial, Single-Dose, distributed nationwide in the US. The recall was initiated on 27 Sep 2019 and the FDA has classified it as Class III.
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-0167-2020
- FDA event ID
- 83959
- Recalling firm
- Arbor Pharmaceuticals, Atlanta, GA
- Manufacturer
- Wilshire Pharmaceuticals
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Sep 2019
- FDA classified
- 30 Oct 2019
- Reported
- 6 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Sep 2019 | Recall initiated by company | |
| 30 Oct 2019 | Classified by FDA | +33 days |
| 6 Nov 2019 | 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
Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01
Where it was distributed
Nationwide in the US
Questions about this recall
Is Testosterone Cypionate Injection, USP, 2000 mg/ Vial, Single-Dose recalled?
Yes. Arbor Pharmaceuticals recalled Testosterone Cypionate Injection, USP, 2000 mg/ Vial, Single-Dose on 27 Sep 2019. The recall is Class III and its status is Terminated. Recall number D-0167-2020.
Why was it recalled?
Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
Which lots are affected?
lot# 23803.002B, Exp 07/2020; 23803.005A, Exp 01/2021
Where was it sold?
Nationwide in the US
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Arbor Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nymalize (nimodipine) oral solution, 60 mg/-Dose Cups recalled | Arbor Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Cetylev (acetylcysteine) effervescent tablets recalled | Arbor Pharmaceuticals | Packaging Defects | 14 states |
Other Testosterone Cypionate recalls
All 23| 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 Injection, USP, 200mg/mL, CIII recalledTestosterone Cypionate | Sun Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, 200mg/ml recalledTestosterone Cypionate | Sun Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |