CLASS II Drug recall · Reported 14 Nov 2018 · FDA Enforcement Report
Testosterone 25 mg pellet recalled by Qualgen
Qualgen is recalling Testosterone 25 mg pellet (, distributed nationwide in the US. The recall was initiated on 17 Oct 2018 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-0234-2019
- FDA event ID
- 81346
- Recalling firm
- Qualgen, Edmond, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2018
- FDA classified
- 7 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Oct 2018 | Recall initiated by company | |
| 7 Nov 2018 | Classified by FDA | +21 days |
| 14 Nov 2018 | 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
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 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lots: C235 BUD: 11/10/2018; C241 BUD: 11/17/2018; C251 BUD: 12/8/2018; C265 BUD: 12/28/2018; D008 BUD: 1/9/2019; D018 BUD: 1/19/2019; D022 BUD: 1/25/2019; D032 BUD: 2/7/2019; D037 BUD: 2/13/2019; D057 BUD: 3/8/2019; D061 BUD: 3/14/2019; D069 BUD: 3/23/2019
Where was it sold?
Nationwide.
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
13 other products · FDA event 81346More recalls from Qualgen
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Testosterone 200 mg Pellet recalled by Qualgen | Qualgen | Packaging Defects | Nationwide |
| 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 12.5mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |
| Drug | CLASS II | Estradiol 25mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |
Other Testosterone Pellet recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Testosterone 200 mg Pellet recalled by Qualgen | Qualgen | Packaging Defects | Nationwide |
| Drug | CLASS II | Testosterone 12.5mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |
| Drug | CLASS II | Testosterone 87.5mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |
| Drug | CLASS II | Testosterone 200mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |
| Drug | CLASS II | Testosterone 37.5 mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |