Medications & Supplements/Prescription Drugs

Endometrin Vaginal Inserts Recalled for Microbial Contamination Risk

Agency Publication Date: June 26, 2023

Summary

Ferring Pharmaceuticals Inc. is recalling two lots of Endometrin (progesterone) Vaginal Insert 100mg. The recall was issued because the products were manufactured with deviations from quality standards, creating a potential risk for microbial contamination. No injuries or infections have been reported at this time.

Risk

Microbial contamination in a vaginal product can introduce bacteria or other harmful organisms into the body, which may lead to infections or other adverse health complications.

What You Should Do

This recall affects Endometrin (progesterone) Vaginal Insert 100mg, which is packaged in a carton of 21 vaginal inserts and includes 21 disposable vaginal applicators.
Check the carton for NDC 55566-6500-03 and specifically look for lot numbers AA200A or AA201A with an expiration date of 12/2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Endometrin (progesterone) Vaginal Insert (100mg)

Variants: 100mg, Vaginal Insert

Lot Numbers:

AA200A (Exp. 12/2025)

AA201A (Exp. 12/2025)

NDC:

55566-6500-03

Packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92494

Status: Resolved

Manufacturer: Ferring Pharmaceuticals Inc

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Distributed To: Nationwide

Agency Last Updated: July 5, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Endometrin (progesterone) Vaginal Insert 100mg, which is packaged in a carton of 21 vaginal inserts and includes 21 disposable vaginal applicators.

Check the carton for NDC 55566-6500-03 and specifically look for lot numbers AA200A or AA201A with an expiration date of 12/2025.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.