Gemcitabine Injection — Class II drug recall D-0714-2026
Ongoing recall by McKesson, reported 2026-07-08, distributed nationwide. Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a re
| Recall number | D-0714-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | McKesson, Irving, TX, United States |
| Recall initiated | 2026-06-10 |
| Classified | 2026-07-21 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 74 units |
| Reason classes | temperature control |
| NDC | 00143-9340, 00143-9340-01, 00143-9341, 00143-9341-01, 00143-9342, 00143-9342-01 |
| Lot numbers | CB0046 |
| Expiration dates | 2027-06 |
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 for recall
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
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-0714-2026. 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.