CLASS II Drug recall · Reported 14 Jun 2017 · FDA Enforcement Report
Estradiol 12.5 mg pellet 99.5% Estradiol recalled by Qualgen
Qualgen is recalling Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in, and, Sterile Office, distributed nationwide in the US. The recall was initiated on 19 Apr 2017 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-0894-2017
- FDA event ID
- 77064
- Recalling firm
- Qualgen, Edmond, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Apr 2017
- FDA classified
- 7 Jun 2017
- Reported
- 14 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Hormones & Birth Control
Timeline
| 19 Apr 2017 | Recall initiated by company | |
| 7 Jun 2017 | Classified by FDA | +49 days |
| 14 Jun 2017 | 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
CGMP deviations- Lack of Quality Assurance
Product as listed by the FDA
Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
CGMP deviations- Lack of Quality Assurance
Which lots are affected?
Lot# C044; Exp. 03/14/18 Lot# C013; Exp. 07/23/17 Lot# B150; Exp. 12/6/17 Lot# B119; Exp. 10/18/17 Lot# B097; Exp. 09/14/17 Lot# B061; Exp. 07/5/17
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
7 other products · FDA event 77064This product is part of a recall event; the main page for the event is Estradiol 20 mg pellet 99.5% Estradiol recalled by Qualgen.
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 |
Other Estradiol Pellet Estradiol recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF recalled | Qualgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Estradiol 6 mg pellet 99.5% Estradiol recalled by Qualgen | Qualgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Estradiol 25 mg pellet 99.5% Estradiol recalled by Qualgen | Qualgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Estradiol 22 mg pellet 99.5% Estradiol recalled by Qualgen | Qualgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Estradiol 10 mg pellet 99.5% Estradiol recalled by Qualgen | Qualgen | Manufacturing (CGMP) Deviations | Nationwide |