Why it was recalled
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
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
Lot numbers, UPCs & expiration codes
Lot #: CB0046, Exp. Date 06/2027
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0714-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 10, 2026
- FDA report date
- Jul 8, 2026
- Quantity
- 74 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- McKesson
Original FDA data
Every field from FDA enforcement report D-0714-2026, exactly as published.
Show all FDA fields
- City
- Irving
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 99262
- Address
- 6555 State Highway 161
- Code information
- Lot #: CB0046, Exp. Date 06/2027
- Postal code
- 75039-2402
- Report date
- Jul 8, 2026
- Product type
- Drugs
- Recall number
- D-0714-2026
- Classification
- Class II
- Recalling firm
- McKesson
- Product quantity
- 74 units
- Reason for recall
- Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 10, 2026
- Initial firm notification
- Telephone
- Center classification date
- Jul 21, 2026