CLASS II Drug recall · Reported 18 Nov 2015 · FDA Enforcement Report
Biest CP 80/20 (Estradiol (E2) Trit recalled by the Compounder
the Compounder is recalling Biest CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)), distributed nationwide in the US. The recall was initiated on 10 Mar 2015 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-0185-2016
- FDA event ID
- 71535
- Recalling firm
- the Compounder, Aurora, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2015
- FDA classified
- 10 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 10 Mar 2015 | Recall initiated by company | |
| 10 Nov 2015 | Classified by FDA | +245 days |
| 18 Nov 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product as listed by the FDA
BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it was distributed
Nationwide
Questions about this recall
Is Biest CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) recalled?
Yes. the Compounder recalled Biest CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) on 10 Mar 2015. The recall is Class II and its status is Terminated. Recall number D-0185-2016.
Why was it recalled?
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Which lots are affected?
Lot # 02182015:78@22, Exp 2/18/2016; Lot # 02182015:98@23, Exp 2/18/2016
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 the Compounder
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Biest TD 80/20 (Estradiol USP Micronized recalled by the Compounder | the Compounder | Other | Nationwide |
| Drug | CLASS II | Biest TD 80/20 (Estradiol (E2) Trit recalled by the Compounder | the Compounder | Other | Nationwide |
| Drug | CLASS II | Biest TD 80/20 (Estradiol (E2) Trit recalled by the Compounder | the Compounder | Other | Nationwide |
| Drug | CLASS II | Estriol (E3) W/V (weight/volume) Versabase 3MG/ML recalled | the Compounder | Other | Nationwide |
| Drug | CLASS II | Biest CP 80/20 (Estradiol (E2) Trit recalled by the Compounder | the Compounder | Other | Nationwide |