The U.S. pharmaceutical industry saw a five-year low for the number of recall events with a total of 274 for all of 2021. In the fourth quarter of 2021, pharmaceutical product recalls dropped by 23.3% to 66 events, marking the lowest number of fourth-quarter recalls in the past five years.
While the number of product recall events went down, the number of units rose sharply to 102.6 million, a 169.1% increase compared to the third quarter. A single recall for failed stability specification for acetaminophen accounted for 51.5 million units - more than half of all total units impacted in the quarter. Compared to 2020, the year finished with 20.3% fewer recall events, but nearly double the number of units impacted.
Failed specifications was the top cause of fourth-quarter product recalls both in terms of events and units, largely driven by the acetaminophen recall. In terms of units, cGMP deviations had the second most units impacted with 47.9 million. Most of these were from two separate benzene-related events – a recall of 23.5 million units of sunscreen and another recall involving 22.8 million units of deodorant powder spray.