Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Jun 8, 2018 (8 years ago)

TESTOSTERONE 200 mg PELLET

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

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp Date.

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 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01

Affected NDC 69761-0120-01

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

Drug: Testosterone

Recalling firm
Qualgen, LLC
NDC code
69761-120-01
Origin
OK, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0893-2018 · 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 Qualgen, LLC

All 2018 recalls