CLASS III Drug recall · Reported 17 Mar 2021 · FDA Enforcement Report
Menopur 75 IU, (menotropins for injection) recalled
Ferring Pharmaceuticals is recalling Menopur 75 IU, (menotropins for injection), packaged as a) dose vials of Menotropins for, distributed nationwide in the US. The recall was initiated on 2 Mar 2021 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-0299-2021
- FDA event ID
- 87382
- Recalling firm
- Ferring Pharmaceuticals, Parsippany, NJ
- Brand
- Menopur
- Manufacturer
- Ferring Pharmaceuticals Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Mar 2021
- FDA classified
- 11 Mar 2021
- Reported
- 17 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Mar 2021 | Recall initiated by company | |
| 11 Mar 2021 | Classified by FDA | +9 days |
| 17 Mar 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-2; b) Professional Sample Kit: 3 single dose vials of Menotropins for injection, 3 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-3; Rx Only, Manufactured for Ferring Pharmaceuticals Inc. Parsippany. NJ 07054. Diluent manufactured for Ferring Pharmaceuticals Inc.
Where it was distributed
Distributed nationwide in the USA.
Questions about this recall
Why was it recalled?
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Which lots are affected?
Lots# a) P12585AC, Exp. Date 31-Mar-2020 P12677AA, Exp. Date 31-Mar-2020 P12678AA, Exp. Date 31-Jul-2020 P12679AA, Exp. Date 31-Jul-2020 P12680EA, Exp. Date 31-Jul-2020 P15461AA, Exp. Date 31-Jul-2020 P15462AA, Exp. Date 31-Aug-2020 P15463AA, Exp. Date 31-Aug-2020 P15870AA, Exp. Date 31-Aug-2020 P15872AA, Exp. Date 31-Aug-2020 P16099AA, Exp. Date 31-Aug-2020 P16100AA, Exp. Date 30-Sep-2020 P16101AC, Exp. Date 30-Sep-2020 P16248AA, Exp. Date 30-Sep-2020 P16770AA, Exp. Date 30-Nov-2020 P16771AA, Exp. Date 30-Nov-2020 R10623AA, Exp. Date 31-Jan-2021 R10624AA, Exp. Date 31-Jan-2021 R10980AA, Exp. Date 31-Jan-2021 R11085AA, Exp. Date 31-Jan-2021 R11086AA, Exp. Date 31-Jan-2021 R11088AA, Exp. Date 28-Feb-2021 R11343AA, Exp. Date 28-Feb-2021 R11416AA, Exp. Date 28-Feb-2021 R11417AA, Exp. Date 28-Feb-2021 R11418AA, Exp. Date 28-Feb-2021 R11419AA, Exp. Date 28-Feb-2021 R12100AA, Exp. Date 28-Feb-2021 R12101AA, Exp. Date 28-Feb-2021 R12102AA, Exp. Date 31-Mar-2021 R12263CA, Exp. Date 31-Mar-2021 R12264AA, Exp. Date 31-Mar-2021 R12598AA, Exp. Date 31-Mar-2021 R12599AA, Exp. Date 31-Mar-2021 R12858AA, Exp. Date 30-Apr-2021 R12859AA, Exp. Date 30-Apr-2021 R12860AA, Exp. Date 31-Jul-2021 R12861AA, Exp. Date 31-Jul-2021 R14321AA, Exp. Date 30-Nov-2021 R14753AA, Exp. Date 31-Jul-2021 R14865AA, Exp. Date 31-Jul-2021 R14866AA, Exp. Date 31-Jul-2021 R15132AA, Exp. Date 31-Aug-2021 R15133AA, Exp. Date 31-Aug-2021 R15330AA, Exp. Date 31-Aug-2021 R15331AA, Exp. Date 31-Aug-2021 R15332AA, Exp. Date 31-Aug-2021 R15333AA, Exp. Date 31-Aug-2021 R15969AA, Exp. Date 30-Sep-2021 R15970AA, Exp. Date 30-Sep-2021 R16231AA, Exp. Date 30-Sep-2021 R16379AA, Exp. Date 31-Oct-2021 R16403AA, Exp. Date 31-Oct-2021 R16405AA, Exp. Date 31-Oct-2021 R16660AA, Exp. Date 31-Oct-2021 R16696AA, Exp. Date 30-Nov-2021 R16770AA, Exp. Date 31-Oct-2021 R17019AA, Exp. Date 31-Oct-2021 R17020AA, Exp. Date 30-Nov-2021 R17148AA, Exp. Date 30-Nov-2021 S11615AA, Exp. Date28-Feb-2022 S11616AA, Exp. Date 28-Feb-2022 S11617AA, Exp. Date 28-Feb-2022 S11618AA, Exp. Date 28-Feb-2022 S11619AA, Exp. Date 28-Feb-2022 S11620AA, Exp. Date 28-Feb-2022 S11621AA, Exp. Date 28-Feb-2022 S11623AA, Exp. Date 28-Feb-2022 S12026AA, Exp. Date 31-Mar-2022 S12413AA, Exp. Date 31-Mar-2022 S12436AA, Exp. Date 31-Mar-2022 S12437AA, Exp. Date 30-Apr-2022 S12438AA, Exp. Date 31-May-2022 S12439AA, Exp. Date 31-May-2022 b) Physician Samples P16101AA, Exp. Date 30-Sep-2020 R15332AC, Exp. Date 31-Aug-2021 S11625AA, Exp. Date 28-Feb-2022
Where was it sold?
Distributed nationwide in the USA.
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.
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