CLASS III Drug recall · Reported 16 Jul 2014 · FDA Enforcement Report
Endometrin (progesterone) Vaginal Insert 100 mg USP, 21 inserts recalled
Ferring Pharmaceuticals is recalling Endometrin (progesterone) Vaginal Insert 100 mg USP, 21 inserts, distributed nationwide in the US. The recall was initiated on 19 Sep 2013 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-1426-2014
- FDA event ID
- 66604
- Recalling firm
- Ferring Pharmaceuticals, Parsippany, NJ
- Brand
- Endometrin
- Manufacturer
- Ferring Pharmaceuticals Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Sep 2013
- FDA classified
- 9 Jul 2014
- Reported
- 16 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 19 Sep 2013 | Recall initiated by company | |
| 9 Jul 2014 | Classified by FDA | +293 days |
| 16 Jul 2014 | 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
Discoloration; due to prolonged heat exposure.
Product as listed by the FDA
ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Discoloration; due to prolonged heat exposure.
Which lots are affected?
Lot Number:Expiry Date - 0804.182B-1:07/14; 0804.183B-1:07/14; 0804.185A-1:08/14; 0804.186B-1:08/14; 0804.187B-1:08/14; 0804.210A-1:12/14; 0804.212A-1:12/14; 0804.213A-1:12/14; 0804.214A-1:12/14; 0804.216B-1:12/14; 0804.223B-1:02/15 0804.225B-1:03/15
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 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.
More recalls from Ferring Pharmaceuticals
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Endometrin (progesterone) Vaginal Insert 100mg recalled | Ferring Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Zoma-Jet 5 Demonstration Kit recalled by Ferring Pharmaceuticals | Ferring Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Zoma-Jet 10 Demonstration Kit recalled by Ferring Pharmaceuticals | Ferring Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Menopur 75 IU, (menotropins for injection) recalledMenopur | Ferring Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Ddavp Nasal Spray (desmopressin acetate) 10 mcg recalled | Ferring Pharmaceuticals | Potency & Assay | Nationwide |
Other Progesterone recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Progesterone Injection USP, 500mg per (50mg/mL) Multiple Dose Vial recalledProgesterone | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Progesterone Injection, USP, 500 mg per (50mg/mL) Multiple-Dose Vial recalledProgesterone | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Progesterone 200 mg, Compounded, Rx recalled by Coast Quality Pharmacy | Coast Quality Pharmacy | Foreign Material | Nationwide |
| Drug | CLASS II | Progesterone 100mg/ML Inj # Ethyl Oleate Injectable recalled | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Progesterone 100mg/ML Mdv Oil Injection recalled | First Royal Care Co. LLC | Sterility | 7 states |