CLASS II Drug recall · Reported 14 Nov 2018 · FDA Enforcement Report
Estradiol 18mg pellet recalled by Qualgen
Qualgen is recalling Estradiol 18mg 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-0228-2019
- 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
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
Where it was distributed
Nationwide.
Questions about this recall
Is Estradiol 18mg pellet ( recalled?
Yes. Qualgen recalled Estradiol 18mg pellet ( on 17 Oct 2018. The recall is Class II and its status is Terminated. Recall number D-0228-2019.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lots: C255 BUD: 12/13/2018
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 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 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 5mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |
| Drug | CLASS II | Estradiol 25mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |