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Pharmaceutical

U.S. sector spotlight

The Sedgwick brand protection recall index is the essential reference for pharmaceutical manufacturers seeking impartial and reliable perspective on past, present and future product recall data and safety trends.

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While U.S. pharmaceutical recall events fell to five-year low in 2021, the second-highest number of impacted units was recorded.

The latest edition of our highly coveted product recall index report offers a comprehensive year-in-review of 2021 pharmaceutical product recall data and trends, and insightful predictions for the remainder of 2022. It is the only report of its kind that aggregates and tracks essential data to help pharmaceutical business leaders mitigate litigation and reputational damage caused by product recalls and other in-market product incidents.

While we strongly recommend you download and read the whole index, the following excerpt provides a glimpse into the key insights and analysis from the pharmaceutical sector.

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-20%

U.S. pharmaceutical recalls fell in 2021


23%

failed specification: leading recall cause


264M

impacted pharmaceutical units in 2021


The U.S. pharmaceutical landscape

As the COVID-19 pandemic entered its second year, supply chain issues remained a challenge across the pharmaceutical industry. In June 2021, the White House released a report on its 100-day review of U.S. critical supply chains, which provided the new Administration’s view of the pharmaceutical industry.

One trend that may be a result of manufacturers having to change suppliers and ingredients, was a rise in benzene-related recalls. This has been an issue primarily for products that depend on an aerosol spray propellant where manufacturers have substituted butane for alcohol as an ingredient in the propellent.

One of the biggest changes for the FDA that was brought about by the pandemic was a dramatic rise in the use of Emergency Use Authorizations (EUAs). They have allowed the FDA access to a wealth of knowledge about why medication errors happen (because medication error reporting is mandatory with drugs under EUAs, not voluntary as it is with approved drugs). There has been some criticism, however, over how many products – both pharmaceutical and medical devices – were granted EUA status. The industry should already be planning for post-pandemic life and how to navigate the transition from EUAs to normal regulatory approvals.

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Recall index report

Get unrivaled analysis and perspective on the latest pharmaceutical product safety trends and regulation.

Download the report

By the numbers: 2021 U.S. pharmaceutical recalls

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.

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Recall index report

Get unrivaled analysis and perspective on the latest pharmaceutical product safety trends and regulation.

Download the report

2022 strategic considerations

While product recall numbers are important, they are only part of the story. Here's what you should take away from pharmaceutical product safety developments in 2022:

  • Pharmaceutical products marketed under EUAs must comply with mandatory medication error reporting, which is voluntary for drugs that have gone through the normal FDA approval process. With more data available, companies have more exposure. Are you ready to act quickly if there is a product recall? How will you respond if there are a large number of medication errors for your product?
  • The Pharmaceutical Research and Manufacturers of America’s (PhRMA’s) updated Code on Interactions with Health Care Professionals is in effect. While the new code is not legally binding, companies that adopt its rules are less likely to run afoul of federal fraud and abuse laws like the Anti-Kickback Statute. If you operate in a jurisdiction where these guidelines have become law, have you made any changes to events to comply with the new code? Have you considered voluntarily incorporating these guidelines as a way to help protect your reputation and mitigate risk?
Contact us

Recall index report

Get unrivaled analysis and perspective on the latest pharmaceutical product safety trends and regulation.

Download the report

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Whether you’re planning for — or currently facing — a product recall, market withdrawal or any other in-market product incident, our experts are on hand to support you.

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