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# Quarter 3 Drug and Device Recalled Units Higher: Sedgwick Index
- URL: https://www.fdaweb.com/quarter-3-drug-and-device-recalled-units-higher-sedgwick-index/
- Published: 2025-12-04T12:00:00.000Z
- Updated: 2026-09-14T15:28:20.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5160328

The Sedgwick Recall Index for the third quarter of 2025 shows that while the total 97 drug recalls was the same as in the second quarter, the number of recalled units increased 137% to 44.56 million. The [report](https://marketing.sedgwick.com/acton/media/4952/2025-us-recall-index-download?ref=fdaweb.com) says the average recall size more than doubled between the second and third quarters.

Year-to-date, there have been 281 drug recalls with 91.07 million units affected. Sedgwick says that compares to the 275 recalls affecting 22.04 million units in the first three quarters of 2024.

The leading cause of 2025 third quarter recalls was failed specifications, followed by current good manufacturing practice deviations and foreign materials. There were 58 unique companies in the third quarter recalls.

Looking at medical devices, Sedgwick says the number of recalls fell 4.8% percent in the third quarter from 251 to 239\. However, the number of units increased 237% from 32.17 million units to 108.39 million units.

There have been 726 device recalls year-to-date, covering 159.15 million units. Sedgwick says that is considerably lower than the 800 recalls of 408.29 million units in the third quarter of 2024.

Device failure was the leading cause of recalls, followed by software concerns and mislabeling.

The number of Class 1 recalls remained steady at 36, the report says, while the number of affected units went up from 4.29 million units to 50.02 million units, the highest level in more than 20 years.