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U.S. Department of Health and Human Services

About FDA

Number of Class I recalls classified

Dictionary: Using the recall process, manufacturers may voluntarily remove a drug from the marketplace if a drug quality defect is found. OC classifies the recall (or recommends classification in some cases) based on the level of public health risk. A Class I recall is the most significant recall. A recall may be done for a single product dosage form or for multiple dosage forms, or multiple products.

Information is current as of March 31, 2014.

Fiscal Year - 2014

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TimeTargetNumber
Oct 2013N/A0
Nov 2013N/A2
Dec 2013N/A8
Jan 2014N/A8
Feb 2014N/A0
Mar 2014N/A7
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 25

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

Number products impacted by Class I recalls

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A0
Nov 2013N/A2
Dec 2013N/A16
Jan 2014N/A11
Feb 2014N/A0
Mar 2014N/A13
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 42

Number of Class II recalls classified

Fiscal Year - 2014

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TimeTargetNumber
Oct 2013N/A8
Nov 2013N/A16
Dec 2013N/A18
Jan 2014N/A25
Feb 2014N/A18
Mar 2014N/A10
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 95

Number products impacted by Class II recalls

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A9
Nov 2013N/A33
Dec 2013N/A330
Jan 2014N/A638
Feb 2014N/A24
Mar 2014N/A58
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 1,092

Number of Class III recalls classified

Fiscal Year - 2014

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TimeTargetNumber
Oct 2013N/A3
Nov 2013N/A4
Dec 2013N/A9
Jan 2014N/A6
Feb 2014N/A8
Mar 2014N/A6
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 36

Number products impacted by Class III recalls

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A3
Nov 2013N/A5
Dec 2013N/A26
Jan 2014N/A14
Feb 2014N/A15
Mar 2014N/A14
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 77

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.