Gemcitabine Injection, Solution
FDA Recall NDC 0143-9342
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Gemcitabine (NDC 0143-9342). A significant event, classified as Class II, was initiated on Jun 10, 2026 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment."
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
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Jun 10, 2026
Jul 08, 2026
74 units
Recall Profile & Regulatory Data
Event ID
99262
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
McKesson
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01
Batch or Lot Expiration Information
Lot# : CB0046, Exp. Date 06/2027
Affected Packages Involved in this Recall
0143-9340-01Product
0143-9341-01Product
0143-9342-01Product
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.
