UnratedDrug recall · FDA · Published March 2, 2021
Ferring Menopur 75 IU Recall: Failed pH Specifications
Ferring Pharmaceuticals recalls Menopur 75 IU (menotropins for injection) due to failed pH specifications in 0.9% Sodium Chloride. This affects specific vial lots manufactured between 2020-2022.
“Ferring Menopur 75 IU Recall: Failed pH Specifications.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36497-ferring-menopur-75-iu-recall-failed-ph-specifications. Based on FDA recall #D-0299-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0299-2021%22&limit=1).
Ferring Pharmaceuticals Inc recalled Menopur 75 IU (menotropins for injection) due to failed pH specifications in the diluent, the FDA said on March 2, 2021. The Class III recall was voluntary and initiated by the firm.
How to tell if you have it
Brand: Ferring
Product: Menopur 75 IU (menotropins for injection)
NDC 55566-7501-2: 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL
NDC 55566-7501-3: Professional Sample Kit with 3 single dose vials of each component
Lots a) P12585AC through R17148AA and b) Physician Samples P16101AA, R15332AC, S11625AA
The hazard
The recall addresses out-of-specification pH results for the 0.9% Sodium Chloride, USP diluent included in the product packaging.
Context
GovInfoNow's records show Ferring Pharmaceuticals Inc has conducted 8 other recalls since August 23, 2012. Recent brand actions include a June 12, 2023 recall of Endometrin Vaginal Inserts for microbial contamination risk and a March 11, 2021 recall of ZOMA-Jet 10 Kits due to defective delivery systems. Other recent recalls of similar products include Cipla Diclofenac Gel (Dec. 22, 2025) and Sun Pharmaceutical Fluocinolone Acetonide Solution (Dec. 30, 2025).
How to tell if you have this one
Check the product label for the specific vial lot numbers listed in the recall (e.g., P12585AC, P12677AA, etc.) and the expiration date. This product is only available by prescription.
Brand
Ferring
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the lot number and expiration date on the vial to determine if it's affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Check the vial lot number on the product label. The recall lists specific lot numbers from P12585AC (expiring 31-Mar-2020) to S12439AA (expiring 31-May-2022).
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0299-2021 (March 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0299-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.