FDA Drug Recalls

1,803 recalls · Class II, newest first

Jun 18, 2013 Class II · Moderate risk

Methylphenidate Hydrochloride Extended-Release Capsules

Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Terminated Dissolution failure Teva Pharmaceuticals USA, Inc. NDC 0093-5347-01 D-848-2013

Jun 18, 2013 Class II · Moderate risk

Methylphenidate Hydrochloride Extended-Release Capsules

Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Terminated Dissolution failure Teva Pharmaceuticals USA, Inc. NDC 0093-5346-01 D-847-2013

Jun 18, 2013 Class II · Moderate risk

Theraflu Cold and Flu

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health D-763-2014

Jun 18, 2013 Class II · Moderate risk

Theraflu Exte

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health D-762-2014

Jun 18, 2013 Class II · Moderate risk

NeoCitran Extra Strength Non-Drowsy Cold & Sinus

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health NDC 0067-7116-06 D-761-2014

Jun 18, 2013 Class II · Moderate risk

NeoCitran DM Cough & Cold

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health D-760-2014

Jun 18, 2013 Class II · Moderate risk

NeoCitran Extra Strength Cold & Flu

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health D-759-2014

Jun 18, 2013 Class II · Moderate risk

NeoCitran

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health D-758-2014

Jun 18, 2013 Class II · Moderate risk

NeoCitran Extra Strength

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health D-757-2014

Jun 18, 2013 Class II · Moderate risk

Theraflu Nighttime Severe Cold & Cough

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health NDC 0043-6256-06 D-756-2014

Jun 18, 2013 Class II · Moderate risk

Theraflu Flu & Chest Congestion

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health NDC 0043-0483-06 D-755-2014

Jun 18, 2013 Class II · Moderate risk

Theraflu Sugar-Free Nighttime Severe Cold & Cough

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health NDC 0067-6318-06 D-754-2014

Jun 18, 2013 Class II · Moderate risk

Theraflu MAX-D Severe Cold & Flu

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health NDC 0067-6427-06 D-753-2014

Jun 18, 2013 Class II · Moderate risk

Theraflu Multi-Symptom Severe Cold

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health NDC 0067-6426-06 D-752-2014

Jun 18, 2013 Class II · Moderate risk

Theraflu

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health NDC 0067-6319-06 D-751-2014

Jun 18, 2013 Class II · Moderate risk

Theraflu Severe Cold & Cough powder packets containing Daytime formula

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health D-750-2014

Jun 18, 2013 Class II · Moderate risk

Theraflu Daytime Severe Cold & Cough

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health NDC 0043-6257-06 D-749-2014

Jun 18, 2013 Class II · Moderate risk

Theraflu Flu & Sore Throat

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health NDC 0067-7916-06 D-748-2014

Jun 17, 2013 Class II · Moderate risk

Belladonna Alkaloids/PB

Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.

Terminated Particulate / foreign matter Physicians Total Care, Inc. NDC 54868-0031-04 D-826-2013

Jun 13, 2013 Class II · Moderate risk

ChloraPrep With Tint

Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.

Terminated Sterility / contamination CareFusion 213, LLC D-1442-2014

Jun 11, 2013 Class II · Moderate risk

Sodium Bicarbonate Powder

Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.

Terminated Particulate / foreign matter Church & Dwight Inc D-801-2013

Jun 11, 2013 Class II · Moderate risk

Sodium Bicarbonate Powder

Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.

Terminated Particulate / foreign matter Church & Dwight Inc D-800-2013

Jun 11, 2013 Class II · Moderate risk

Sodium Bicarbonate Powder

Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.

Terminated Particulate / foreign matter Church & Dwight Inc D-799-2013

Jun 11, 2013 Class II · Moderate risk

Sodium Bicarbonate Powder

Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.

Terminated Particulate / foreign matter Church & Dwight Inc D-798-2013

Jun 11, 2013 Class II · Moderate risk

Sodium Bicarbonate Powder

Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.

Terminated Particulate / foreign matter Church & Dwight Inc D-797-2013

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061