Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Sep 27, 2019 (7 years ago)

Testosterone Cypionate Injection

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was 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

Cause type: Labeling / mix-up

Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.

What was recalled

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

Affected NDC 52536-0625-01

Compare with the code on your package — it is the most precise check available.

Drug: Testosterone

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Testosterone Cypionate
NDC 52536-0625
200 mg/mL Injection
Intramuscular
Wilshire Pharmaceuticals Rx · CIII
Recalling firm
Arbor Pharmaceuticals Inc.
NDC code
52536-625-01
Origin
GA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0167-2020 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Testosterone recalls

See all
Class II · Moderate risk

Testosterone 200mg

Presence of Foreign substance - potential presence of metal particulate matter

Ongoing Particulate / foreign matter F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0329-2026
Class II · Moderate risk

Testosterone 100mg

Presence of Foreign substance - potential presence of metal particulate matter

Ongoing Particulate / foreign matter F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0328-2026
Class II · Moderate risk

Testosterone 75mg

Presence of Foreign substance - potential presence of metal particulate matter

Ongoing Particulate / foreign matter F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0327-2026

Other recalls by Arbor Pharmaceuticals Inc.

All 2019 recalls
Class I · High risk

Cetylev (acetylcysteine)

Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.

Terminated Packaging defect Arbor Pharmaceuticals Inc. NDC 24338-700-10 D-0105-2017