CLASS III Drug recall · Reported 17 Apr 2019 · 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 29 Mar 2019 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-1084-2019
- FDA event ID
- 82504
- Recalling firm
- X-Gen Pharmaceuticals, Horseheads, NY
- Brand
- Clonidine
- Manufacturer
- XGen Pharmaceuticals DJB, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Mar 2019
- FDA classified
- 8 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 29 Mar 2019 | Recall initiated by company | |
| 8 Apr 2019 | Classified by FDA | +10 days |
| 17 Apr 2019 | Published in enforcement report | +9 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: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Product as listed by the FDA
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.
Where it was distributed
Nationwide in the USA.
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 29 Mar 2019. The recall is Class III and its status is Terminated. Recall number D-1084-2019.
Why was it recalled?
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.
Which lots are affected?
Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020;
Where was it sold?
Nationwide in the USA.
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 II | Nystatin Topical Powder, USP, 100,000 USP units per gram recalled | X-Gen Pharmaceuticals | Particulate Matter | 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 |