Browse Drug Recalls

1,141 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,141 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 1,141 FDA drug recalls in 2017.

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DateProductReasonClassFirm
Aug 22, 2017 Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Skin antisepsis and oral cleansing. Contains Three 2-packs of 2% Chlorhexidin... 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 Suction Toothbrush Compatible with ... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluco... 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 Antiseptic Oral Rinse, C... 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 with 0.12% Chlorhexidine Gluconate (CHG) O... 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 Toothbrush with Perox-A-Mint solution. Contains 1... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL ... Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used... Class II Pfizer Inc.
Aug 22, 2017 HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in c... Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used... Class II Pfizer Inc.
Aug 22, 2017 Toothette Oral Care Daily Oral Cleansing Kit Petite Size with Antiseptic Oral... 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 with 0.12% Chlorhexidine Gluconate (CHG) O... 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 Corinz. Contains: 1 Covered Yankau... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-... Crystallization: Product is being recalled due to the manufacturer's recall due to the presence o... Class II RemedyRepack Inc.
Aug 22, 2017 Toothette Oral Care Suction Swabs with Perox-A-Mint solution and Mouth Moistu... 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 Toothbrush with Antiseptic Oral Rinse. Contains 1... 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 Suction Toothbrush Compatible with ... 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 Antiseptic Oral Rinse 1.5 fl.oz/44 ml. Sage Products, Inc... 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. ... 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 Petite Oral Cleansing & Suctioning System 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 Q.CARE Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, Su... 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 q8. Contains 1 Covered Yankauer Suc... 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 Swab System 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
Aug 22, 2017 Toothette Oral Care Short Term Oral Care 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 Short Term Oral Swab System 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
Aug 22, 2017 QCare Oral Cleansing and Suctioning System with Corinz. Includes: Two (2) Suc... 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 q4. Contains 1 Covered Yankauer, 2 Untreat... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solu... Microbial contamination of Non-sterile Products; potential B. cepacia contamination Class II Centurion Labs, LLC
Aug 22, 2017 Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution and Mouth M... 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 Single Use System with Perox-A-Mint solution and Mouth M... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufacture... Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specificatio... Class III Wockhardt Usa Inc.
Aug 22, 2017 Toothette Oral Care Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Ma... Microbial contamination of Non-sterile Products; potential B. cepacia contamination Class II Centurion Labs, LLC
Aug 22, 2017 Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yan... 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 Petite Oral Cleansing & Suctioning System 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 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 Toothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2... 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 with 0.12% Chlorhexidine Gluconate (CHG) O... 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 Suction Toothbrush Compatible with ... 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 Single Use System with Antiseptic Oral Rinse and Mouth Mo... 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 Suction Toothbrush Compatible with ... 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 q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and... 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 Swab System 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
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 QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Glucon... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, ... Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... Class II Sage Products Inc
Aug 22, 2017 Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Con... 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 Q Care & Suctioning System. Contains 1 Covered Yankauer,... 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 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

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.