Clonidine HCL Injection — Class III drug recall D-1084-2019
Terminated recall by X-Gen Pharmaceuticals Inc., reported 2019-04-17, distributed nationwide. Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg
| Recall number | D-1084-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | X-Gen Pharmaceuticals Inc., Horseheads, NY, United States |
| Recall initiated | 2019-03-29 |
| Classified | 2019-04-08 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2021-06-02 |
| Distributed | Nationwide (US) |
| Quantity | 24,966 vials |
| Reason classes | labeling, potency |
| NDC | 39822-2000, 39822-2000-01, 39822-2010, 39822-2010-01 |
| Lot numbers | PMXA1917, PMXA1937, PMXA1938 |
| Expiration dates | 2020-09, 2020-11 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1084-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.