Use cautionDrug recall · FDA · Published February 9, 2026
Meitheal Cetrorelix Acetate Injection Kit Recall: Missing or Duplicated Needles
Meitheal Pharmaceuticals recalls Cetrorelix Acetate injection kits with missing or duplicated needles. This could cause injection errors. Return the kit to the pharmacy for a replacement.
“Meitheal Cetrorelix Acetate Injection Kit Recall: Missing or Duplicated Needles.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31486-meitheal-cetrorelix-acetate-injection-kit-recall-missing-or-duplicated-needles. Based on FDA recall #D-0340-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0340-2026%22&limit=1).
Meitheal Pharmaceuticals, Inc. recalled Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, due to a defective delivery system that may result in missing or duplicated needles, the FDA said on Feb. 9, 2026.
How to tell if you have it
Brand: Meitheal Pharmaceuticals
Product: Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only
NDC: 71288-558-90
Lot Code: Q4E0112A
Expiration Date: 30 Apr 2027
Quantity: 16,477 kits
The hazard
The recall addresses a defective delivery system involving missing or duplicated needles within the injection kit. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Meitheal Pharmaceuticals, Inc. has issued two other recalls since Jan. 27, 2021, including a Sept. 3, 2021, recall for failed impurities and a Jan. 27, 2021, recall for label mix-ups. Other recent recalls of similar products include Lupin Ganirelix Acetate Injection (Nov. 13, 2025), Cipla Lanreotide Injection (March 13, 2026), and Reliance Pemetrexed Injection (June 24, 2026).
How to tell if you have this one
Check for the product name 'Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only'. The kit was manufactured by Meitheal Pharmaceuticals in Chicago, IL with NDC 71288-558-90 and lot number Q4E0112A.
Brand
Meitheal Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Kit for Needles
Inspect the kit for missing or duplicated needles before use.
Contact Pharmacy
Return the kit to your pharmacy for a replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 9 days after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class II
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0340-2026 (February 9, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0340-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.