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Showing 4421–4440 of 14370 results

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Carbidopa-Levodopa Tablets (Mayne) – Tablet Mix-Up (2020)

Product Mix-Up: A foreign tablet was found in bottle.

Class IIModerate

FDAMar 2, 2020Nationwide• Mayne Pharma Inc

Daytrana Patches (Noven) – Delivery System Defect (2020)

Defective Delivery System: Out of specification for mechanical peel and shear.

Class IIModerate

FDAMar 2, 2020Nationwide• Noven Therapeutics, LLC

Daytrana Patches (Noven) – Delivery System Defect (2020)

Defective Delivery System: Out of specification for mechanical peel and shear.

Class IIModerate

FDAMar 2, 2020Nationwide• Noven Therapeutics, LLC

Folic Acid Supplement (National Vitamin) – label error (2020)

Customer reports of label error. Front panel states strength of 1000 mg although supplement fact is correct in stating 1000 mcg.

Class IIILow

FDAFeb 28, 2020AZ, FL, GA +16 more• National Vitamin Company Inc

Quetiapine Extended-Release 300mg (Harvard) – Incorrect Insert (2020)

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Class IIILow

FDAFeb 27, 2020Nationwide• The Harvard Drug Group

Elelyso Injection (Pfizer) – Loose Vial Crimps (2020)

Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.

Class IIModerate

FDAFeb 27, 2020Nationwide• Pfizer Inc.

Quetiapine Extended-Release 150mg (Harvard) – Incorrect Insert (2020)

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Class IIILow

FDAFeb 27, 2020Nationwide• The Harvard Drug Group

Quetiapine Extended-Release 50mg (Harvard) – Incorrect Insert (2020)

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Class IIILow

FDAFeb 27, 2020Nationwide• The Harvard Drug Group

Quetiapine Extended-Release 200mg (Harvard) – Incorrect Insert (2020)

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Class IIILow

FDAFeb 27, 2020Nationwide• The Harvard Drug Group

Chia/Flax Boost Supplement (Organic By Nature) – unapproved herbicide (2020)

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop

Class IIILow

FDAFeb 24, 2020Nationwide• Organic By Nature, Inc.

Ertapenem 1GM (Redline) – Processing Controls (2020)

Lack Of Processing Controls

Class IIModerate

FDAFeb 24, 2020IN, NE• Redline Pharmacy Solutions

Zoledronic Acid Injection (Breckenridge) – Impurity Specs (2020)

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.

Class IIILow

FDAFeb 24, 2020Nationwide• Breckenridge Pharmaceutical, Inc

Daptomycin 500mg (Redline) – Processing Controls (2020)

Lack Of Processing Controls

Class IIModerate

FDAFeb 24, 2020IN, NE• Redline Pharmacy Solutions

Vancomycin 900mg (Redline) – Processing Controls (2020)

Lack Of Processing Controls

Class IIModerate

FDAFeb 24, 2020IN, NE• Redline Pharmacy Solutions

Green Power (Springboard) - Unapproved Herbicide (2020)

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop

Class IIILow

FDAFeb 24, 2020Nationwide• Organic By Nature, Inc.

Organic Superfoods (RAWr! Life) - Unapproved Herbicide (2020)

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop

Class IIILow

FDAFeb 24, 2020Nationwide• Organic By Nature, Inc.

Organic Super Protein (Touchstone Essentials) - Unapproved Herbicide (2020)

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop

Class IIILow

FDAFeb 24, 2020Nationwide• Organic By Nature, Inc.

Super Greens Juice (Touchstone Essentials) – Unapproved Herbicide (2020)

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop

Class IIILow

FDAFeb 24, 2020Nationwide• Organic By Nature, Inc.

Sodium Chloride Ophthalmic Ointment (Akorn) – Particulate Matter (2020)

Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.

Class IIILow

FDAFeb 21, 2020Nationwide• Akorn, Inc.

Walgreens Sodium Chloride Ointment (Akorn) – Particulate Matter (2020)

Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.

Class IIILow

FDAFeb 21, 2020Nationwide• Akorn, Inc.

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