411 PRESS

FDA Recalls

Food, drug, and medical device recalls from the U.S. Food and Drug Administration, classified by FDA Class I/II/III. 1,986 records.

1,986
Total Recalls
456
Class I
1,372
Class II
158
Class III

All Recalls

Browse recalls by hazard or company.

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

Mirabegron Extended-Release Tablets

CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

Zydus Pharmaceuticals (USA) Inc
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

SILDENAFIL CITRATE USP

CGMP Deviations:Noted during FDA inspection

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

TADALAFIL USP

CGMP Deviations:Noted during FDA inspection

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

TADALAFIL USP

CGMP Deviations:Noted during FDA inspection

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

TADALAFIL USP

CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP
Critical
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class I

Optiray Imaging Bulk Package-350

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Liebel-Flarsheim Company LLC
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

SEMAGLUTIDE 0.9mg (0.9 mg/mL)

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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

SEMAGLUTIDE 10mg (5mg/mL)

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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

SEMAGLUTIDE 12.5MG (2.5MG/mL)

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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

SEMAGLUTIDE 2.25MG (0.9 mg/mL)

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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

SEMAGLUTIDE 2.5mg (1mg/mL)

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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

SEMAGLUTIDE 20mg (5mg/mL)

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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

SEMAGLUTIDE 4.5mg (0.9 mg/mL)

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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

SEMAGLUTIDE 5mg (1mg/mL)

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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

SEMAGLUTIDE 6.75mg (4.5 mg/mL)

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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

SEMAGLUTIDE 7.5mg (5mg/mL)

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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

SEMAGLUTIDE 9mg (4.5 mg/mL)

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care
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.
Info
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class III

Dabigatran Etexilate Capsules

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity...

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

Dabigatran Etexilate Capsules

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity...

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

Dabigatran Etexilate Capsules

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity...

Ascend Laboratories
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.

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