Cetrorelix injection kits recalled over missing or duplicated needles inside
Meitheal Pharmaceuticals is recalling 16,477 Cetrorelix Acetate for Injection kits over a defective delivery system, with needles either missing from or duplicated within the kit.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites missing or duplicated needles in a kit with no stated clinical consequence or reported harm.
Plain-English summary
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, single-dose kit, Rx only, made for Meitheal Pharmaceuticals of Chicago, Illinois, under NDC 71288-558-90, is being recalled.
The reason given in the enforcement record is a defective delivery system: missing or duplicated needles within the injection kit.
The record lists 16,477 kits from lot Q4E0112A, expiry 30 Apr 2027. Distribution was nationwide in the US. The FDA has classified the action as Class II.
A kit without its needle cannot be used as supplied. The record reports no injuries. Patients should contact their prescriber or pharmacy if a kit is missing a needle rather than substituting one.
The recalled product
- Product
- CETRORELIX ACETATE (CETRORELIX ACETATE)
- Brand
- CETRORELIX ACETATE
- Manufacturer
- Meitheal Pharmaceuticals, Inc
- Category
- Drug — Fertility injection
- Affected units
- 16,477
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Q4E0112A
- Exp.: 30 Apr 2027
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Meitheal Pharmaceuticals, Inc
See all →- ModerateGlycopyrrolate Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2021-09-22
- SevereCisatracurium Besylate Injection Recalled Due to Labeling Error
FDA (Drugs) · 2021-03-03
Same hazard · defective delivery system
See all →- HighAmneal Recalls Exenatide Injection Pens Due to Potential Empty Delivery System
FDA (Drugs) · 2026-09-30
- HighAIRSUPRA Albuterol and Budesonide Inhalation Aerosol Recalled for Defective Delivery System
FDA (Drugs) · 2025-05-28
- HighLorazepam Oral Syringes Recalled Due to Defective Delivery System Causing Leakage
FDA (Drugs) · 2025-03-12
- ModerateVarithena Administration Pack Recalled Due to Incorrect Syringe Connector Type
FDA (Drugs) · 2024-12-18
- HighDaytrana Methylphenidate Transdermal Patches Recalled for Defective Delivery System
FDA (Drugs) · 2023-03-29
Similar recalls
- SevereEMD Serono Recalls Cetrotide Vials Due to Missing Rubber Stoppers
FDA (Drugs) · 2020-07-15
- ModerateCetrorelix Acetate Injectable Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2023-06-07
- SevereFDA Recalls Imitrex STATdose Systems Due to Sterility Concerns
FDA (Drugs) · 2014-01-01
- HighMethotrexate Injectable Vials Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-01
- ModerateCenturion Medical Recalls Port Access Infusion Kits with 1-Inch Needles
FDA (Devices) · 2019-11-06
- HighCompounded Semaglutide Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-09-11