Cardinal Health Inc. recalls RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Read the official notice →- Date
- 2025-08-13
- Country
- United States
- Brand
- Cardinal Health
- Product
- RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
- Classification
- Class II
- Units
- Nationwide Within the U.S.
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Cardinal Health recalls
- 2025-12-17
USCardinal Health 200, LLC recalls ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T…
Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the country of Canada.Official notice →- 2025-10-29
- US
Cardinal Health 200, LLC recalls Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3…
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
FDA · DeviceCardinal Health 200, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2025-09-03
- US
Cardinal Health Inc. recalls Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx…
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
- 2025-06-18
- US
Cardinal Health 200, LLC recalls SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
FDA · DeviceCardinal Health 200, LLCDomestic US distribution to AK, CA, FL, MA, TX. International distribution to…Official notice → - 2025-06-04
- US
Cardinal Health 200, LLC recalls Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
FDA · DeviceCardinal Health 200, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2025-05-07
- US
Cardinal Health Inc. recalls Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose…
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically,…
Other drugs & medical recalls in the United States
- 2025-08-13
- US
B BRAUN MEDICAL INC recalls Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air…
FDA · DeviceB BRAUN MEDICAL INCUS distribution to AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, ME, MI, MN,…Official notice → - US
ICU Medical, Inc. recalls Plum Duo Infusion System, List Number: 400020401
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St,…
Presence of foreign substance: identified as aluminum.
- US
Direct Rx recalls Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc.,…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- US
Alembic Pharmaceuticals Limited recalls Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- US