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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. 1,907 records.

1,907
Total Recalls
416
Class I
1,341
Class II
150
Class III

All Recalls

Browse recalls by hazard or company.

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

Azelaic Acid Gel

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty,...

Glenmark Pharmaceuticals Inc.
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Glycopyrrolate Injection

Presence of Particulate Matter: Hair was found in product

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

Lidocaine HCl Injection

Presence of Particulate Matter: Hair was found in products

Fresenius Kabi USA
Info
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class III

Lidolog Kit

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Asclemed USA Inc.
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Rising

Presence of Precipitate: medication was crystallizing and particles floating in the bottle

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

BD ChloraPrep Clear

Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the...

CareFusion 213
Warning
Packaged food on grocery store aisle shelves — representative photo for FDA food recall
Class II

Man Fon Inc

Undeclared colors: Yellow#5, and Yellow#6.

Man Fon
Info
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class III

Dabigatran etexilate Capsules

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis...

Ascend Laboratories
Info
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class III

Dabigatran etexilate Capsules

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis...

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

Cinacalcet Hydrochloride Tablets

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

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

Cinacalcet Hydrochloride Tablets

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

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

Cinacalcet Hydrochloride Tablets

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

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

Dextroamphetamine Saccharate

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

Lannett Company Inc.
Critical
Packaged food on grocery store aisle shelves — representative photo for FDA food recall
Class I

1

Contaminated with Salmonella

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

AUDIOLOGIST'S CHOICE

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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

CAREone

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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

CVS Health

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Bell Pharmaceuticals

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