X-Gen Recalls Clonidine HCl Injection Due to Label Error
X-Gen Pharmaceuticals recalls Clonidine HCl Injection vials because the label incorrectly states the strength as 500 mcg/mL instead of 100 mcg/mL.
Use caution until it’s fixed
Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
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What happened, in plain English
X-Gen Pharmaceuticals Inc. is recalling Clonidine HCl Injection, 1000 mcg/10 mL single-dose vials due to a labeling error. The side label incorrectly declares the strength as "Each mL contains 500 mcg Clonidine Hydrochloride" when it actually contains 100 mcg/mL. This discrepancy could lead to medication errors. Read more at govinfonow.com/recall/45937-x-gen-pharmaceuticals-inc-recalls-clonidine-hcl-injection-1000-mcg.
Source Summary by GovInfoNow · govinfonow.com/recall/45937-x-gen-pharmaceuticals-inc-recalls-clonidine-hcl-injection-1000-mcg · Updated October 12, 2026 · FDA enforcement record: FDA #D-1444-2014
Cite this page
“X-Gen Recalls Clonidine HCl Injection Due to Label Error.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45937-x-gen-pharmaceuticals-inc-recalls-clonidine-hcl-injection-1000-mcg. Based on FDA recall #D-1444-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1444-2014%22&limit=1).
Why it’s dangerous
The label error misstates the concentration of the active ingredient, potentially causing healthcare providers to administer an incorrect dose. While the actual content is 100 mcg/mL, the label suggests 500 mcg/mL, which could lead to confusion and potential dosing errors.
Who’s affected
Healthcare providers and patients who received the specific lot of Clonidine HCl Injection distributed nationwide before July 17, 2014. Patients relying on accurate dosage information for this prescription drug are at risk.
How to tell if you have this one
Check for Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL), 10 mL Single Dose Vial manufactured by X-Gen Pharmaceuticals Inc. Look for NDC 39822-2000-1 and Lot PLNB1412 with an expiration date of 12/15.
- Brand
X-Gen Pharmaceuticals- Category
Drug
What to do — step by step
Verify Product Details
Check the NDC number (39822-2000-1) and Lot number (PLNB1412) on the vial to confirm if it is part of this recall.
Contact Healthcare Provider
If you have this product, consult your healthcare provider or pharmacist for guidance on how to proceed with the medication.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1444-2014 (July 17, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1444-2014 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.