June 2026 FDA Recall Gemcitabine by Mckesson
D-0714-2026 - Temperature Abuse
This Class II drug recall was voluntarily initiated by Mckesson on June 10, 2026 for the product Gemcitabine. The FDA reported the reason for recall as temperature abuse. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0714-2026
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
06-10-2026
07-08-2026
74 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
McKesson
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
