Why it was recalled
Defective Delivery System: Missing or duplicated needles within the injection kit
Product description
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.
Lot numbers, UPCs & expiration codes
Lot Q4E0112A, Exp.: 30 Apr 2027
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0340-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 9, 2026
- FDA report date
- Feb 18, 2026
- Quantity
- 16,477 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Meitheal Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-0340-2026, exactly as published.
Show all FDA fields
- City
- Chicago
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 98386
- Address
- 8700 W Bryn Mawr Ave Ste 600s
- Code information
- Lot Q4E0112A, Exp.: 30 Apr 2027
- Postal code
- 60631-3529
- Report date
- Feb 18, 2026
- Product type
- Drugs
- Recall number
- D-0340-2026
- Classification
- Class II
- Recalling firm
- Meitheal Pharmaceuticals, Inc
- Product quantity
- 16,477 kits
- Reason for recall
- Defective Delivery System: Missing or duplicated needles within the injection kit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Feb 9, 2026
- Initial firm notification
- Letter
- Center classification date
- Feb 23, 2026