FDA Drug recall D-0714-2026
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: THYMO…
- FDA Drug
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of 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: THYMO… by Mckesson, citing temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0714-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-10 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mckesson |
| Distribution | US |
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
Reason
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Identifiers
| ndc | 0143-9340-01 |
|---|---|
| ndc | 0143-9341-01 |
| ndc | 0143-9342-01 |
| code_info | Lot #: CB0046, Exp. Date 06/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0714-2026%22
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