Class II U.S. Food and Drug Administration

McKesson Gemcitabine Injection, 1 g per 26.3 mL , 26.3 mL Single-Dose Vial recall: Temperature Abuse: Product was stored incorrectly in a controlled room

Recall published 4 months ago

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

The hazard: Temperature control failure

This product spent time outside the temperature range it needs. Cold-chain failures are recalled on principle, because the evidence of growth arrives too late to be useful.

What the notice says: Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

Why it matters: The product went outside its required temperature range in storage or transport. That does not prove bacteria grew in it, but it removes the control that was supposed to stop them.

Symptoms and when to call a doctor

If you have eaten it, watch for the usual food-poisoning pattern — stomach cramps, nausea, diarrhoea, sometimes fever — and seek care for a high fever, bloody stools, persistent vomiting or signs of dehydration.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0714-2026
Published
July 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
McKesson
Product type
Prescription & OTC drugs
Units affected
74 units
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: CB0046, Exp. Date 06/2027

Products covered by this recall

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

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • CB0046
  • 2027 — 74 units

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 06
  • 2027 — 74 units

NDC number

On the carton and again on the bottle or blister label.

  • 0143-9341-01

Package size

Match the net weight or the piece count on the front of the pack.

  • 26.3 mL
  • 38 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Temperature

McKesson — This product spent time outside the temperature range it needs. Cold-chain failures are recalled on principle, because the evidence of growth arrives too late to be useful.

  1. Do not eat it, even if it looks and smells normal — that is exactly what the recall anticipates.
  2. Bin it sealed or return it for a refund using the lot code from the pack.
  3. Clean the shelf it sat on if any packaging has leaked.
  4. If you refroze it after it thawed, discard it rather than keeping it for cooking later.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: McKesson — 6555 State Highway 161, Irving, TX, 75039-2402

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was McKesson prescription & otc drugs recalled?

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment. Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code CB0046, 2027 — 74 units; best-by date 06 or 2027 — 74 units. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Do not eat it, even if it looks and smells normal — that is exactly what the recall anticipates.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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