Infuvite Adult recall
FDA recall D-0401-2025 · initiated Apr 25, 2025
Mckesson Medical-Surgical Inc. Corporate Office recalled Infuvite Adult in Apr 2025 — an FDA Class II recall (D-0401-2025) because Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 15
Details
- Product
- Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product of Canada, NDC 54643-5649-1
- Recalling company
- Mckesson Medical-Surgical Inc. Corporate Office
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed to Medical Facilities in MS and FL.
- Initiated
- Apr 25, 2025
- FDA report date
- May 7, 2025
This recall is linked to a product we cover: Infuvite Adult →
Frequently asked
- Was Infuvite Adult recalled?
- Mckesson Medical-Surgical Inc. Corporate Office recalled Infuvite Adult in Apr 2025 — an FDA Class II recall (D-0401-2025) because Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Infuvite Adult recalled?
- Per the FDA enforcement record, the reason for recall D-0401-2025 was: Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
- Is a recalled Infuvite Adult dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Infuvite Adult are affected?
- Distributed: Distributed to Medical Facilities in MS and FL.. The recall covers these lots — Lot #: AA2279, Exp 8/31/26; AA2383, Exp 9/30/26. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0401-2025.