Qualgen Estradiol Pellets Recall: CGMP Quality Issues
Qualgen recalls estradiol pellets due to quality assurance failures. Products may not meet safety standards for subcutaneous use. Affected lots expire by August 2017.
Recall notice
CGMP deviations- Lack of Quality Assurance
Contact the company
What happened, in plain English
Qualgen is recalling estradiol pellets that were manufactured with CGMP deviations. This means the product may not meet safety standards for subcutaneous use, which could pose risks to patients. Read more at govinfonow.com/recall/41649-qualgen-estradiol-pellets-recall-cgmp-quality-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/41649-qualgen-estradiol-pellets-recall-cgmp-quality-issues · Updated October 8, 2026 · FDA enforcement record: FDA #D-0891-2017
Cite this page
“Qualgen Estradiol Pellets Recall: CGMP Quality Issues.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41649-qualgen-estradiol-pellets-recall-cgmp-quality-issues. Based on FDA recall #D-0891-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0891-2017%22&limit=1).
Why it’s dangerous
The product was made with CGMP deviations, meaning quality assurance processes failed. This could lead to the product not meeting safety standards for medical use, though the exact risk is unclear.
Who’s affected
Patients prescribed estradiol pellets for subcutaneous use. Those with the specific lot numbers listed in the recall are most at risk.
How to tell if you have this one
Check the product label for the lot numbers: C022 (exp. 08/21/17), B143 (exp. 11/22/17), B104 (exp. 09/27/17), B073 (exp. 08/01/17), or B052 (exp. 06/13/17). The product is a sterile, prescription-only estradiol pellet for subcutaneous use.
- Brand
Qualgen- Category
Drug
All 8 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-0889-2017 | Estradiol 25 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 69761-025-01,; Lot # C031; Exp. 03/2/18 Lot # B077; Exp. 08/10/17 Lot # B040; Exp. 05/16/17 | 1,153 pellets. |
| D-0890-2017 | Estradiol 22 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 69761-022-01; Lot # B128; Exp. 11/1/17 Lot # B075; Exp. 08/3/17 | 1,666 pellets. |
| D-0891-2017 | Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01; Lot# C022; Exp. 08/21/17 Lot# B143; Exp. 11/22/17 Lot# B104; Exp. 09/27/17 Lot# B073; Exp. 08/1/17 Lot# B052; Exp. 06/13/17 | 4,468 pellets. |
| D-0892-2017 | Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.; Lot# C018; Exp. 08/2/17 Lot# B151; Exp. 12/7/17 Lot# B108; Exp. 10/3/17 Lot# B095; Exp. 09/12/17 Lot# B062; Exp. 07/6/17 Lot# B035; Exp. 05/2/17 Lot# B133; Exp. 11/4/17 | 6,361 pellets. |
| D-0893-2017 | Estradiol 15 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: 69761-015-01; Lot# C028; Exp. 02/28/18 Lot# C005; Exp. 07/11/17 Lot# B142; Exp. 11/21/17 Lot# B114; Exp. 10/10/17 Lot# B099; Exp. 09/16/17 Lot# B069; Exp. 07/12/17 Lot# B048; Exp. 06/6/17 | 6,227 pellets |
| D-0894-2017 | 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; 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 | 4,883 pellets. |
| D-0895-2017 | Estradiol 10 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: 69761-010-01; Lot# C021; Exp. 08/20/17 Lot# B160, Exp. 12/29/17 Lot# B140; Exp. 11/15/17 Lot# B107; Exp. 09/29/17 Lot# B079; Exp. 08/15/17 Lot# B046; Exp. 06/01/17 | 5,260 pellets. |
| D-0896-2017 | Estradiol 6 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: 69761-006-01.; Lot# C046; Exp. 03/15/18 Lot# C025; Exp. 08/23/17 Lot# B159; Exp. 12/28/17 Lot# B121; Exp. 10/10/17 Lot# B118; Exp. 10/17/17 Lot# B086; Exp. 08/29/17 Lot# B068; Exp. 07/11/17 Lot# B053; Exp. 06/14/17 Lot# B034; Exp. 04/26/17 | 4,815 pellets. |
What to do — step by step
Check Product Label
Look for the lot numbers listed in the recall: C022, B143, B104, B073, or B052.
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 4.4 years 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.
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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-0891-2017 (April 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0891-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.