Cetrorelix Acetate for Injection (Kit) recall
FDA recall D-0340-2026 · initiated Feb 9, 2026
Meitheal Pharmaceuticals, Inc recalled Cetrorelix Acetate for Injection (Kit) in Feb 2026 — an FDA Class II recall (D-0340-2026) because Defective Delivery System: Missing or duplicated needles within the injection kit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Delivery System: Missing or duplicated needles within the injection kit
Another quality failure
A quality failure that does not fit the categories above.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 16,477 kits
Details
- 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.
- Recalling company
- Meitheal
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Feb 9, 2026
- FDA report date
- Feb 18, 2026
Frequently asked
- Was Cetrorelix Acetate for Injection (Kit) recalled?
- Meitheal Pharmaceuticals, Inc recalled Cetrorelix Acetate for Injection (Kit) in Feb 2026 — an FDA Class II recall (D-0340-2026) because Defective Delivery System: Missing or duplicated needles within the injection kit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cetrorelix Acetate for Injection (Kit) recalled?
- Per the FDA enforcement record, the reason for recall D-0340-2026 was: Defective Delivery System: Missing or duplicated needles within the injection kit
- Is a recalled Cetrorelix Acetate for Injection (Kit) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cetrorelix Acetate for Injection (Kit) are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot Q4E0112A, Exp.: 30 Apr 2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0340-2026.