CLASS II ONGOING Drug recall · Reported 7 May 2025 · FDA Enforcement Report
Infuvite Adult, multiple vitamins injection, Baxter recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 and Five of Vial 2, distributed in Florida, Mississippi. The recall was initiated on 25 Apr 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0401-2025
- FDA event ID
- 96744
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Brand
- Infuvite Adult
- Manufacturer
- Sandoz Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Apr 2025
- FDA classified
- 1 May 2025
- Reported
- 7 May 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 25 Apr 2025 | Recall initiated by company | |
| 1 May 2025 | Classified by FDA | +6 days |
| 7 May 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Distributed to Medical Facilities in MS and FL.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: AA2279, Exp 8/31/26; AA2383, Exp 9/30/26
Where was it sold?
Distributed to Medical Facilities in MS and FL.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96744| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medroxyprogesterone Acetate Injectable Suspension recalled | Mckesson Medical-Surgical Inc. Corporate Office | Potency & Assay | FL, MS |
More recalls from Mckesson Medical-Surgical Inc. Corporate Office
All 276| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived recalled | Mckesson Medical-Surgical Inc. Corporate Office | Other | Nationwide |
| Drug | CLASS II | Prolia (denosumab), injection, 60mg/mL, For Subcutaneous Use Only recalledProlia | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Drug | CLASS II | Benlysta (belimumab) for injection, 400 mg/ vial recalledBenlysta | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Drug | CLASS II | Evenity, (romosozumab -aqqg) injection, 105mg recalledEvenity | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Device | CLASS II | Abbott Diagnostics Alinity I Anti-ccps Reagent recalled | Mckesson Medical-Surgical Inc. Corporate Office | Device Malfunction | Nationwide |
Other Multiple Vitamins recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Infuvite PEDiatric Pharmacy, kit in 1 carton fill recalled by SandozInfuvite Pediatric | Sandoz | Other | Nationwide |