FDA Recall D-0340-2026
Meitheal Pharmaceuticals, Inc · Chicago, IL
Class II Ongoing 94 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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.
Reason for recall
Defective Delivery System: Missing or duplicated needles within the injection kit
Recall record
- Recall number
D-0340-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide
- Recall initiated
- 2026-02-09
- Classified by FDA Center
- 2026-02-23
- FDA published
- 2026-02-18
- Recalling firm
- Meitheal Pharmaceuticals, Inc
- Firm location
- Chicago, IL
Drug identification
- Brand name(s)
- CETRORELIX ACETATE
- Generic name(s)
- CETRORELIX ACETATE
- Manufacturer(s)
- Meitheal Pharmaceuticals Inc.
- NDC(s)
71288-558- Route(s)
- SUBCUTANEOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.