Cefazolin Sodium injection recalled due to temperature abuse during manufacturing
McKesson Medical-Surgical is recalling 26 cases of Cefazolin Sodium injection due to manufacturing deviations involving temperature abuse. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This FDA Class II recall involves documented manufacturing deviations (temperature abuse) affecting an injectable antibiotic. While no illnesses or injuries have been reported, the manufacturing defect poses a risk of harm to drug safety and efficacy, supporting a Score 3 classification as a risk-of-harm product without reported injury.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Cefazolin Sodium for injection USP in 1G, 50 mL duplex containers (manufactured by B. Braun Medical Inc., NDC 0264-3103-11). The recall affects 26 cases that were distributed nationwide in the United States.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse. Specific lot numbers could not be identified by McKesson for individual consignees; customers have been sent letters with distribution dates and information about affected product.
Healthcare providers who received this product should contact McKesson Medical-Surgical for guidance on returned product and replacement supplies.
The recalled product
- Product
- CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
- Brand
- CEFAZOLIN SODIUM
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Antibiotic
- Affected units
- 26
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 brand · CEFAZOLIN SODIUM
- HighCefazolin Sodium Injectable Recalled Nationwide for Temperature Abuse
FDA (Drugs) · 2022-06-15
- CriticalB. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter
FDA (Drugs) · 2014-05-07
- SevereB. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter
FDA (Drugs) · 2014-05-07
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 →- SevereKayem Foods Recalls Ready-to-Eat Meat and Poultry Due to Temperature Abuse
USDA FSIS · 2026-10-17
- ModerateZoladex Goserelin Implant Recalled Due to Temperature Abuse
FDA (Drugs) · 2026-10-07
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
Similar recalls
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateCardinal Health Recalls Cefazolin Injection Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateMcKesson Recalls Hydralazine Hydrochloride Injection Due to Temperature Abuse
FDA (Drugs) · 2017-04-19
- CriticalB. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter
FDA (Drugs) · 2014-05-07
- SevereSCA Pharmaceuticals Recalls Cefazolin Sodium Bags Due to Leaking
FDA (Drugs) · 2017-06-07
- SevereBaxter Recalls Cefazolin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2026-08-19