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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 - 2013

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TimeTargetNumber
Oct 2012N/A2
Nov 2012N/A6
Dec 2012N/A1
Jan 2013N/A2
Feb 2013N/A6
Mar 2013N/A0
Apr 2013N/A5
May 2013N/A7
Jun 2013N/A2
Jul 2013N/A4
Aug 2013N/A10
Sep 2013N/A1

FY 2013 Total: 46

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 - 2013
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TimeTargetNumber
Oct 2012N/A2
Nov 2012N/A7
Dec 2012N/A4
Jan 2013N/A2
Feb 2013N/A8
Mar 2013N/A0
Apr 2013N/A5
May 2013N/A15
Jun 2013N/A2
Jul 2013N/A4
Aug 2013N/A11
Sep 2013N/A2

FY 2013 Total: 62

Number of Class II recalls classified

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A9
Nov 2012N/A14
Dec 2012N/A13
Jan 2013N/A8
Feb 2013N/A14
Mar 2013N/A18
Apr 2013N/A17
May 2013N/A13
Jun 2013N/A16
Jul 2013N/A21
Aug 2013N/A30
Sep 2013N/A21

FY 2013 Total:194

Number products impacted by Class II recalls

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A25
Nov 2012N/A19
Dec 2012N/A40
Jan 2013N/A9
Feb 2013N/A18
Mar 2013N/A27
Apr 2013N/A59
May 2013N/A165
Jun 2013N/A111
Jul 2013N/A178
Aug 2013N/A61
Sep 2013N/A136

FY 2013 Total: 848

Number of Class III recalls classified

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A4
Nov 2012N/A6
Dec 2012N/A5
Jan 2013N/A6
Feb 2013N/A11
Mar 2013N/A11
Apr 2013N/A10
May 2013N/A11
Jun 2013N/A12
Jul 2013N/A10
Aug 2013N/A12
Sep 2013N/A3

FY 2013 Total:101

Number products impacted by Class III recalls

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A6
Nov 2012N/A14
Dec 2012N/A7
Jan 2013N/A7
Feb 2013N/A12
Mar 2013N/A20
Apr 2013N/A13
May 2013N/A14
Jun 2013N/A17
Jul 2013N/A16
Aug 2013N/A26
Sep 2013N/A3

FY 2013 Total: 155

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.