Browse Drug Recalls

66 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 66 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 66 FDA drug recalls.

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DateProductReasonClassFirm
Aug 22, 2017 Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Q.CareOral Cleansing & Suctioning System q2. Contains 1 Covered Yankauer Suct... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untrea... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yank... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate ... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer a... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG)... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yank... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, C... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Glucona... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Feb 2, 2017 Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Cover... Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Ca... Class III Sage Products Inc
Aug 27, 2014 Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915... Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages test... Class II Sage Products Inc

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.