Prescription Thrombin Product Recalled for Temperature Storage Deviations
McKesson is recalling RECOTHROM (Thrombin Topical Recombinant) because products were subjected to temperature abuse during storage or distribution, causing a cGMP (manufacturing practice) deviation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recalled product represents a risk-of-harm product used for hemostasis; products were subjected to temperature abuse during storage or distribution, constituting a cGMP deviation that may affect stability and efficacy. No illnesses or injuries have been reported, qualifying for Score 3 per the rubric for risk-of-harm products without reported injury.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling RECOTHROM (Thrombin Topical Recombinant), a prescription medication used for hemostasis (stopping bleeding). The recall encompasses 110 cartons, each containing a 5,000-unit vial with sterile sodium chloride diluent and applicator equipment, distributed nationwide. The product is manufactured by Baxter Healthcare Corporation.
The recall was initiated because products experienced temperature abuse during storage or distribution, constituting a current Good Manufacturing Practice (cGMP) deviation.
McKesson Medical-Surgical has notified customers in writing. Each notice includes the date the product was distributed and the dates when impacted inventory may have been shipped. Because McKesson cannot identify the specific lot number delivered to each individual customer, the distribution and shipment dates provided in the notifications are used to determine whether a customer received affected units.
The recalled product
- Product
- RECOTHROM (THROMBIN TOPICAL RECOMBINANT)
- Brand
- RECOTHROM
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Hemostatic
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 130 products in this recall →Related recalls
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · temperature abuse
See all →- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- SevereCrab Cakes Sold to Food Service Recalled for Botulism Risk
FDA (Food) · 2026-04-15
- CriticalUDENYCA syringes recalled after cartons were stored at room temperature
FDA (Drugs) · 2026-02-18