Qualgen Testosterone Pellets Recall: Lack of Sterility Assurance
Qualgen recalls testosterone pellets with potential lack of sterility. These products may cause infections if used improperly. Check your product details to see if you are affected.
Lower-risk recall
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
Qualgen is recalling testosterone pellets that may not be sterile, which could lead to infections if used. This recall affects specific batches sold between November 2018 and March 2019. Read more at govinfonow.com/recall/39490-qualgen-testosterone-pellets-recall-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/39490-qualgen-testosterone-pellets-recall-lack-of-sterility-assurance · Updated October 6, 2026 · FDA enforcement record: FDA #D-0234-2019
Cite this page
“Qualgen Testosterone Pellets Recall: Lack of Sterility Assurance.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39490-qualgen-testosterone-pellets-recall-lack-of-sterility-assurance. Based on FDA recall #D-0234-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0234-2019%22&limit=1).
Why it’s dangerous
The product lacks assurance of sterility, meaning it might not be clean enough to prevent infections. This could happen if the product is used without proper medical oversight.
Who’s affected
People who have been prescribed these testosterone pellets by a doctor. Those using the product without medical supervision are not affected.
How to tell if you have this one
Check the product label for the NDC codes 69761-125-01 or 69761-125-30. The batch numbers (C235 to D069) and expiration dates (from November 10, 2018, to March 23, 2019) are listed on the packaging.
- Brand
Qualgen- Category
Drug
All 14 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0225-2019 | Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013; Lots; C262 BUD: 12/20/2018; D067 BUD: 03/21/2019; D072 BUD: 03/28/2019 | — |
| D-0226-2019 | Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013; Lots: C236 BUD: 11/13/2018 | — |
| D-0227-2019 | Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013; Lots: C253 BUD: 12/12/2018; D016 BUD: 1/18/2019 | — |
| D-0228-2019 | Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013; Lots: C255 BUD: 12/13/2018 | — |
| D-0229-2019 | Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013; Lots: C238 BUD: 11/14/2018 | — |
| D-0230-2019 | Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013; Lots: D007 BUD: 01/09/2019; D060 BUD: 3/14/2019 | — |
| D-0231-2019 | Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013; Lots: C232 BUD: 11/3/2018; C239 BUD: 11/14/2018; C246 BUD: 11/29/2018; C260 BUD: 12/19/2018; D004 BUD: 1/4/2019; D017 BUD: 1/18/2019; D023 BUD: 1/26/2019; D053 BUD: 3/6/2019 | — |
| D-0232-2019 | Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013; Lots: C261 BUD: 12/20/2018 | — |
| D-0233-2019 | Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013; Lots: C230 BUD: 11/1/2018; C233 BUD: 11/3/2018; C234 BUD: 11/9/2018; C237 BUD: 11/13/2018; C240 BUD: 11/15/2018; C242 BUD: 11/20/2018; C244 BUD: 11/27/2018; C248 BUD: 12/4/2018; C250 BUD: 12/6/2018; C252 BUD: 12/12/2018; C256 BUD: 12/14/2018; C258 BUD: 12/18/2018; C264 BUD: 12/27/2018; D006 BUD: 1/8/2019; D009 BUD: 1/10/2019; D013 BUD: 1/15/2019; D015 BUD: 1/17/2019; D019 BUD: 1/22/2019; D024 BUD: 1/29/2019; D028 BUD: 2/1/2019; D034 BUD: 2/8/2019; D041 BUD: 2/20/2019; D059 BUD: 3/13/2019; D063 BUD: 3/15/2019; D070 BUD: 3/26/2019 | — |
| D-0234-2019 | 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; 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 | — |
| D-0235-2019 | Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013; Lots: C245 BUD: 11/28/2018; D005 BUD: 1/5/2019; D027 BUD: 1/31/2019; D035 BUD: 2/9/2019; D058 BUD: 3/9/2019 | — |
| D-0236-2019 | Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013; Lots: C247 BUD: 11/30/2018; C249 BUD: 12/5/2018; C266 BUD: 12/29/2018; D012 BUD: 1/12/2019; D029 BUD: 2/2/2019 | — |
| D-0237-2019 | Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013; Lots: C243 BUD: 11/21/2018; D010 BUD: 1/11/2019; D025 BUD: 1/30/2019 | — |
| D-0238-2019 | Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30 count (NDC 69761-222-30) vials, Rx Only, Qualgen, Edmond, OK 73013; Lot: C254 BUD: 12/13/2018 | — |
What to do — step by step
Check Product Details
Look for the NDC codes 69761-125-01 or 69761-125-30 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The product may not be sterile, so it could cause infections. Do not use without consulting a healthcare provider.
What should I do if I have the recalled product?
Contact your healthcare provider to discuss whether you should stop using the product and get a replacement.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0234-2019 (October 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0234-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.