Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 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 | 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 | Toothette Oral Care Suction Swab System 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. ... | 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 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 | Toothette Oral Care Suction Swabs with Perox-A-Mint solution. Contains 2 Suct... | 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 |
| 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 | Q CARE q4 Oral Cleaning & Suctioning System Contains 1 Covered Yankauer and Y... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 18, 2017 | Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cad... | Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets | Class II | Zydus Pharmaceuticals USA Inc |
| Aug 17, 2017 | All Sterile Products within expiry | Lack of Assurance of Sterility . | Class II | Vital Rx, Inc. dba Atlantic Pharmacy and Compou... |
| Aug 16, 2017 | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 16, 2017 | Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 16, 2017 | Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 16, 2017 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, On... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 15, 2017 | L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chi... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. D... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella ... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chic... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, ... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago,... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. De... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. De... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose ... | Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of re... | Class II | Amphastar Pharmaceuticals, Inc. |
| Aug 15, 2017 | PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, ... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, B... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Av... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Ch... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., ... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 10, 2017 | Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL... | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
| Aug 10, 2017 | HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Conce... | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
| Aug 10, 2017 | Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032... | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
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.