Lower risk Drug recall · FDA · Published March 29, 2019

X-Gen Clonidine Injection Label Error: 500mcg vs 100mcg Concentration

X-Gen Pharmaceuticals recalls Clonidine HCL injection vials with incorrect concentration labeling. The label shows 500mcg per mL instead of the correct 100mcg per mL, which could lead to improper dosing.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1084-2019Drug X-Gen ›

Lower-risk recall

Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.

Take action

Contact the company

Recalling firmX-Gen Pharmaceuticals Inc.300 Daniel Zenker Dr · Horseheads, NY 14845-1014

✎ GovInfoNow plain-language explainer

X-Gen Pharmaceuticals is recalling Clonidine HCL injection vials that have a label error showing 500 mcg per mL instead of the correct 100 mcg per mL. This error could lead to incorrect dosing if the vial is used without checking the label. Read more at govinfonow.com/recall/39065-x-gen-clonidine-injection-label-error-500mcg-vs-100mcg-concentration.

Source Summary by GovInfoNow · govinfonow.com/recall/39065-x-gen-clonidine-injection-label-error-500mcg-vs-100mcg-concentration · Updated October 5, 2026 · FDA enforcement record: FDA #D-1084-2019

Cite this page

“X-Gen Clonidine Injection Label Error: 500mcg vs 100mcg Concentration.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39065-x-gen-clonidine-injection-label-error-500mcg-vs-100mcg-concentration. Based on FDA recall #D-1084-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1084-2019%22&limit=1).

The FDA announced on March 29, 2019, that X-Gen Pharmaceuticals Inc. voluntarily recalled Clonidine HCL Injection due to a labeling error listing an incorrect concentration. The agency classified the Class III recall as terminated.

How to tell if you have it

Brand: X-Gen
Product: Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial
NDC: 39822-2000-1
Lots: PMXA1917 (Exp 09/2020); PMXA1937, PMXA1938 (Exp 11/2020)
Quantity: 24,966 vials

The hazard

The side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.

Context

GovInfoNow's records show X-Gen Pharmaceuticals Inc. has 6 other recalls on record since July 17, 2014. Other recent recalls include X-Gen Cyclophosphamide Injection (April 2, 2024), X-Gen Neomycin Sulfate Tablets (March 19, 2021), and X-Gen Levetiracetam Injection (Oct. 11, 2019).

How to tell if you have this one

Check for vials labeled with "500 mcg Clonidine Hydrochloride" per mL on the side carton panel. The product was manufactured for X-Gen Pharmaceuticals in Big Flats, NY with lots numbers PMXA1917 (exp 09/2020) or PMXA1937, PMXA1938 (exp 11/2020).

Brand
X-Gen
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Label
Verify the concentration on the side carton panel is 100 mcg per mL, not 500 mcg per mL.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Mar 29, 2019Firm started the recall
Apr 8, 2019FDA classified it Class III
Apr 17, 2019Published in FDA’s Enforcement Report
Jun 2, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/39065-x-gen-clonidine-injection-label-error-500mcg-vs-100mcg-concentration">X-Gen Clonidine Injection Label Error: 500mcg vs 100mcg Concentration (GovInfoNow)</a>

Where this comes from

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-1084-2019 (March 29, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1084-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.