Hydralazine Hydrochloride Injection — Class III drug recall D-1327-2015
Terminated recall by Fresenius Kabi USA, LLC, reported 2015-08-19, distributed nationwide. Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect
| Recall number | D-1327-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2015-07-28 |
| Classified | 2015-08-12 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2016-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 93,000 vials |
| Reason classes | labeling |
| NDC | 63323-0614, 63323-0614-00, 63323-0614-01 |
| Lot numbers | 6110593 |
| Expiration dates | 2016-11 |
Product
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01
Reason for recall
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
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-1327-2015. 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.