CLASS II Drug recall · Reported 5 Jul 2023 · FDA Enforcement Report
Endometrin (progesterone) Vaginal Insert 100mg recalled
Ferring Pharmaceuticals is recalling Endometrin (progesterone) Vaginal Insert 100mg, distributed nationwide in the US. The recall was initiated on 12 Jun 2023 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-0879-2023
- FDA event ID
- 92494
- Recalling firm
- Ferring Pharmaceuticals, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2023
- FDA classified
- 26 Jun 2023
- Reported
- 5 Jul 2023
- Type
- N/A
- Customers notified by
- N/A
- Reason category
- Sterility
- Drug class
- Hormones & Birth Control
Timeline
| 12 Jun 2023 | Recall initiated by company | |
| 26 Jun 2023 | Classified by FDA | +14 days |
| 5 Jul 2023 | Published in enforcement report | +9 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: potential for Microbial Contamination of Non-Sterile Products
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Which lots are affected?
AA200A, AA201A, Exp. 12/2025
Where was it sold?
USA 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.
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