CLASS III ONGOING Drug recall · Reported 23 Jul 2025 · FDA Enforcement Report
Testosterone 200 mg Pellet recalled by Qualgen
Qualgen is recalling Testosterone 200 mg Pellet, distributed nationwide in the US. The recall was initiated on 16 Jun 2025 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-0517-2025
- FDA event ID
- 97086
- Recalling firm
- Qualgen, Edmond, OK
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 16 Jun 2025
- FDA classified
- 14 Jul 2025
- Reported
- 23 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Jun 2025 | Recall initiated by company | |
| 14 Jul 2025 | Classified by FDA | +28 days |
| 23 Jul 2025 | 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
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
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 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01
Where it was distributed
Nationwide within the United States.
Questions about this recall
Is Testosterone 200 mg Pellet recalled?
Yes. Qualgen recalled Testosterone 200 mg Pellet on 16 Jun 2025. The recall is Class III and its status is Ongoing. Recall number D-0517-2025.
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Which lots are affected?
Lot number: 1043, Exp. Date 2/10/2026
Where was it sold?
Nationwide within the United States.
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 Qualgen
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol 10mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |
| Drug | CLASS II | Estradiol 6 mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |
| Drug | CLASS II | Testosterone 5mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |
| Drug | CLASS II | Estradiol 25mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |
| Drug | CLASS II | Testosterone 5mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |