Class II · Moderate risk
Cetrorelix Acetate for Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Cetrorelix Acetate for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Delivery System: Missing or duplicated needles within the injection kit
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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.
Affected NDC
71288-0558-90
Compare with the code on your package — it is the most precise check available.
Drug: Cetrorelix
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cetrorelix Acetate NDC 71288-0558 |
Kit Subcutaneous |
Meitheal Pharmaceuticals Inc. | Rx |
- Recalling firm
- Meitheal Pharmaceuticals, Inc
- NDC code
- 71288-558-90
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0340-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Cetrorelix recalls
See all
Class II · Moderate risk
Cetrotide (cetrorelix acetate for Injection)
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Other recalls by Meitheal Pharmaceuticals, Inc
All 2026 recalls
Class III · Low risk
Glycopyrrolate Injection
Failed Impurities/Degradation Specifications
Class I · High risk
Cisatracurium Besylate Injection
Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
Other packaging defect recalls from 2026
All packaging defect recalls
Class II · Moderate risk
Exenatide Injection
Defective Delivery System: Possibility of no medication in the prefilled pen.
Class II · Moderate risk
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
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Class II · Moderate risk
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Class II · Moderate risk
PureLife
Defective container:may contain bottles with incomplete seals
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