Drug FDA Class II Ongoing cGMP deviation

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.

Meitheal Pharmaceuticals, Inc Published Feb 18, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Meitheal Pharmaceuticals, Inc or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Defective Delivery System: Missing or duplicated needles within the injection kit

Hazards

Defective Delivery System - Missing or Duplicated Needles · primary

Affected products (1)

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.

CETRORELIX ACETATE · 16,477 kits

NDC: 71288-558, 71288-558-90, 71288-556-02, 71288-557-81

Lot codes: Q4E0112A

Code info: Lot Q4E0112A, Exp.: 30 Apr 2027

Affected areas

Nationwide

Timeline

Initiated

Feb 9, 2026
Published

Feb 18, 2026

Recall number: D-0340-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.