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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ferring Pharmaceuticals Inc: Menopur Fertility Medication Recalled for Improper pH Levels

Agency Publication Date: March 11, 2021
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Summary

Ferring Pharmaceuticals Inc. is voluntarily recalling approximately 1,168,147 units of Menopur 75 IU (menotropins for injection) due to the diluent (0.9% Sodium Chloride) having pH levels that fall outside of required specifications. This recall affects both standard 5-vial cartons and professional sample kits distributed nationwide. Consumers should be aware that the salt water solution used to mix the medication may not meet quality standards, which could potentially impact the medication's effectiveness or safety. Because this is a prescription fertility treatment, patients should immediately contact their healthcare provider or pharmacist for guidance on their specific treatment plan.

Risk

The pH level of the sodium chloride solution used to dissolve the medication is outside the required safety range. Using a solution with an improper pH can lead to irritation at the injection site or may potentially alter the stability and effectiveness of the medication being administered.

What You Should Do

  1. Check your Menopur 75 IU packaging for the following lot numbers: P12585AC, P12677AA, P12678AA, P12679AA, P12680EA, P15461AA, P15462AA, P15463AA, P15870AA, P15872AA, P16099AA, P16100AA, P16101AC, P16248AA, P16770AA, P16771AA, R10623AA, R10624AA, R10980AA, R11085AA, R11086AA, R11088AA, R11343AA, R11416AA, R11417AA, R11418AA, R11419AA, R12100AA, R12101AA, R12102AA, R12263CA, R12264AA, R12598AA, R12599AA, R12858AA, R12859AA, R12860AA, R12861AA, R14321AA, R14753AA, R14865AA, R14866AA, R15132AA, R15133AA, R15330AA, R15331AA, R15332AA, R15333AA, R15969AA, R15970AA, R16231AA, R16379AA, R16403AA, R16405AA, R16660AA, R16696AA, R16770AA, R17019AA, R17020AA, R17148AA, S11615AA, S11616AA, S11617AA, S11618AA, S11619AA, S11620AA, S11621AA, S11623AA, S12026AA, S12413AA, S12436AA, S12437AA, S12438AA, or S12439AA.
  2. If you have a Professional Sample Kit, check for lot numbers P16101AA, R15332AC, or S11625AA.
  3. Verify the expiration dates on your medication, which range from March 31, 2020, to May 31, 2022.
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you should continue using the product or obtain a replacement.
  5. Return any unused, affected medication to your pharmacy to receive a refund.
  6. Contact Ferring Pharmaceuticals Inc. at their Parsippany, New Jersey headquarters for further instructions regarding this recall.
  7. For additional information or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Menopur 75 IU (menotropins for injection) 5-vial carton
Model:
NDC 55566-7501-2
Lot Numbers (74):
P12585AC (Exp. 31-Mar-2020)
P12677AA (Exp. 31-Mar-2020)
P12678AA (Exp. 31-Jul-2020)
P12679AA (Exp. 31-Jul-2020)
P12680EA (Exp. 31-Jul-2020)
P15461AA (Exp. 31-Jul-2020)
P15462AA (Exp. 31-Aug-2020)
P15463AA (Exp. 31-Aug-2020)
P15870AA (Exp. 31-Aug-2020)
P15872AA (Exp. 31-Aug-2020)
P16099AA (Exp. 31-Aug-2020)
P16100AA (Exp. 30-Sep-2020)
P16101AC (Exp. 30-Sep-2020)
P16248AA (Exp. 30-Sep-2020)
P16770AA (Exp. 30-Nov-2020)
P16771AA (Exp. 30-Nov-2020)
R10623AA (Exp. 31-Jan-2021)
R10624AA (Exp. 31-Jan-2021)
R10980AA (Exp. 31-Jan-2021)
R11085AA (Exp. 31-Jan-2021)
R11086AA (Exp. 31-Jan-2021)
R11088AA (Exp. 28-Feb-2021)
R11343AA (Exp. 28-Feb-2021)
R11416AA (Exp. 28-Feb-2021)
R11417AA (Exp. 28-Feb-2021)
R11418AA (Exp. 28-Feb-2021)
R11419AA (Exp. 28-Feb-2021)
R12100AA (Exp. 28-Feb-2021)
R12101AA (Exp. 28-Feb-2021)
R12102AA (Exp. 31-Mar-2021)
R12263CA (Exp. 31-Mar-2021)
R12264AA (Exp. 31-Mar-2021)
R12598AA (Exp. 31-Mar-2021)
R12599AA (Exp. 31-Mar-2021)
R12858AA (Exp. 30-Apr-2021)
R12859AA (Exp. 30-Apr-2021)
R12860AA (Exp. 31-Jul-2021)
R12861AA (Exp. 31-Jul-2021)
R14321AA (Exp. 30-Nov-2021)
R14753AA (Exp. 31-Jul-2021)
R14865AA (Exp. 31-Jul-2021)
R14866AA (Exp. 31-Jul-2021)
R15132AA (Exp. 31-Aug-2021)
R15133AA (Exp. 31-Aug-2021)
R15330AA (Exp. 31-Aug-2021)
R15331AA (Exp. 31-Aug-2021)
R15332AA (Exp. 31-Aug-2021)
R15333AA (Exp. 31-Aug-2021)
R15969AA (Exp. 30-Sep-2021)
R15970AA (Exp. 30-Sep-2021)
Date Ranges: March 31, 2020 - May 31, 2022
Product: Menopur 75 IU Professional Sample Kit
Model:
NDC 55566-7501-3
Lot Numbers:
P16101AA (Exp. 30-Sep-2020)
R15332AC (Exp. 31-Aug-2021)
S11625AA (Exp. 28-Feb-2022)
Date Ranges: September 30, 2020 - February 28, 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87382
Status: Resolved
Manufacturer: Ferring Pharmaceuticals Inc
Sold By: pharmacies; physicians
Manufactured In: United States
Units Affected: 1,155,601 cartons/5 vials per carton 12546 physician samples
Distributed To: Nationwide

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 ยท 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.