Dopamine Hydrochloride Injection, Solution, Concentrate
FDA Recall NDC 0409-5820
Latest: Class II · Status: Ongoing · Initiated Sep 04, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Dopamine Hydrochloride (NDC 0409-5820). A significant event, classified as Class II, was initiated on Sep 04, 2026 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility
Sep 04, 2026
Sep 23, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99824
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.
Batch or Lot Expiration Information
Lot# NL5230, Exp Date:10/2027
Affected Packages Involved in this Recall
0409-5820-11Dopamine Hydrochloride
0409-5820-01Dopamine Hydrochloride
0409-9104-21Dopamine Hydrochloride
0409-9104-20Dopamine Hydrochloride
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
