CLASS III Drug recall · Reported 30 Jul 2014 · FDA Enforcement Report
Clonidine HCl Injection, 1000 mcg/ (100 mcg/mL) Single Dose Vial recalled
X-Gen Pharmaceuticals is recalling Clonidine HCl Injection, 1000 mcg/ (100 mcg/mL) Single Dose Vial, distributed nationwide in the US. The recall was initiated on 17 Jul 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1444-2014
- FDA event ID
- 68729
- Recalling firm
- X-Gen Pharmaceuticals, Horseheads, NY
- Brand
- Clonidine
- Manufacturer
- XGen Pharmaceuticals DJB, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Jul 2014
- FDA classified
- 18 Jul 2014
- Reported
- 30 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 17 Jul 2014 | Recall initiated by company | |
| 18 Jul 2014 | Classified by FDA | +1 day |
| 30 Jul 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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".
Product as listed by the FDA
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.
Where it was distributed
Nationwide
Questions about this recall
Is Clonidine HCl Injection, 1000 mcg/ (100 mcg/mL) Single Dose Vial recalled?
Yes. X-Gen Pharmaceuticals recalled Clonidine HCl Injection, 1000 mcg/ (100 mcg/mL) Single Dose Vial on 17 Jul 2014. The recall is Class III and its status is Terminated. Recall number D-1444-2014.
Why was it recalled?
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".
Which lots are affected?
Lot: PLNB1412, Exp 12/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from X-Gen Pharmaceuticals
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cyclophosphamide for Injection, USP, 500mg/vial recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Cyclophosphamide for Injection, USP, Lyophilized recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Neomycin Sulfate Tablets, USP 500mg recalled by X-Gen Pharmaceuticals | X-Gen Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Levetiracetam Injection, 500 mg/-use vials recalledLevetiracetam | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Clonidine HCL Injection, 1000 mcg/ (100 mcg/mL) Single Dose Vial recalledClonidine | X-Gen Pharmaceuticals | Other | Nationwide |
Other Clonidine recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clonidine Transdermal System, USP, 3 mg/day, supplied recalledClonidine Transdermal System | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS II | Clonidine Transdermal System, USP, 1 mg/day, supplied recalledClonidine Transdermal System | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS II | Clonidine Transdermal System, USP, 2 mg/day, supplied recalledClonidine Transdermal System | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS III | Clonidine Hydrochloride Tablets, USP, 3 mg recalledClonidine Hydrochloride | Unichem Pharmaceuticals Usa | Packaging Defects | Nationwide |
| Drug | CLASS II | Clonidine Transdermal System, USP 3 mg/day, 4 Patches recalledClonidine | Mayne Pharma | Potency & Assay | Nationwide |