CLASS II ONGOING Drug recall · Reported 18 Feb 2026 · FDA Enforcement Report
Cetrorelix Acetate for Injection , 0.25 mg per vial, Single-Dose Kit recalled
Meitheal Pharmaceuticals is recalling Cetrorelix Acetate for Injection , 0.25 mg per vial, Single-Dose Kit, distributed nationwide in the US. The recall was initiated on 9 Feb 2026 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-0340-2026
- FDA event ID
- 98386
- Recalling firm
- Meitheal Pharmaceuticals, Chicago, IL
- Brand
- Cetrorelix Acetate
- Manufacturer
- Meitheal Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Feb 2026
- FDA classified
- 23 Feb 2026
- Reported
- 18 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 9 Feb 2026 | Recall initiated by company | |
| 18 Feb 2026 | Published in enforcement report | +9 days |
| 23 Feb 2026 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Missing or duplicated needles within the injection kit
Product as listed by the FDA
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Defective Delivery System: Missing or duplicated needles within the injection kit
Which lots are affected?
Lot Q4E0112A, Exp.: 30 Apr 2027
Where was it sold?
U.S. 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.
More recalls from Meitheal Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Glycopyrrolate Injection, USP 4mg per Multi-Dose Vials recalled | Meitheal Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Cisatracurium Besylate Injection, USP, 10mg recalledCisatracurium Besylate | Meitheal Pharmaceuticals | Labeling Errors | Nationwide |
Other Cetrorelix recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cetrorelix Acetate for Injection, 0.25 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Cetrotide (cetrorelix acetate for Injection) 0.25 mg recalledCetrotide | EMD Serono | Foreign Material | Nationwide |