CLASS III Drug recall · Reported 11 Jul 2018 · FDA Enforcement Report
Estradiol 20mg Pellet amber vial recalled by Qualgen
Qualgen is recalling Estradiol 20mg Pellet amber vial, distributed nationwide in the US. The recall was initiated on 8 Jun 2018 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-0892-2018
- FDA event ID
- 80203
- Recalling firm
- Qualgen, Edmond, OK
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Jun 2018
- FDA classified
- 29 Jun 2018
- Reported
- 11 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Jun 2018 | Recall initiated by company | |
| 29 Jun 2018 | Classified by FDA | +21 days |
| 11 Jul 2018 | Published in enforcement report | +12 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.
Product as listed by the FDA
ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date.
Which lots are affected?
lot# C211 Exp. date 10/03/2018; C257 Exp. date 12/14/2018 and lot # D001 exp. date 01/02/19
Where was it sold?
Nationwide in the USA
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 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
1 other product · FDA event 80203| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Testosterone 200 mg Pellet amber vial recalled by Qualgen | Qualgen | Other | Nationwide |
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 12.5mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |
| Drug | CLASS II | Estradiol 25mg pellet recalled by Qualgen | Qualgen | Sterility | Nationwide |