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FDA Recalls

Food, drug, and medical device recalls from the U.S. Food and Drug Administration, classified by FDA Class I/II/III. 1,199 records.

1,199
Total Recalls
155
Class I
974
Class II
70
Class III

All Recalls

Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Duloxetine Delayed-Release Capsules

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at...

Ajanta Pharma Ltd.
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Duloxetine Delayed-Release Capsules

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at...

Ajanta Pharma Ltd.
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Duloxetine Delayed-Release Capsules

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at...

Ajanta Pharma Ltd.
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Oasis Tears PF

Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA...

Oasis Medical
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Ascend Laboratories

Failed Dissolution Specifications

Ascend Laboratories
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Enalapril Maleate Tablets

Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test

JB Chemicals and Pharmaceuticals Ltd
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Similasan

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an...

Thea Pharma
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

iVIZIA

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an...

Thea Pharma
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

BD PurPrep

Lack of assurance of Sterility: potential product contamination

CareFusion 213
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

BD PurPrep

Lack of assurance of Sterility: potential product contamination

CareFusion 213
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

GenTeal Tears

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Alcon Research LLC
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Systane

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Alcon Research LLC
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

NAPROXEN ORAL SUSPENSION

Chemical contamination; presence of lead and lithium above specification

Acella Pharmaceuticals
Warning
Packaged food on grocery store aisle shelves — representative photo for FDA food recall
Class II

Loard's Ube Ice Cream - 32 oz

Undeclared Milk, Red #3, Red #40, Blue #1, Blue #2.

Silver Moon LP dba Loard's Ice Cream

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