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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala,... | Marketed Without an Approved NDA/ANDA | Class II | Shata Trading, 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 |
| 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 17, 2017 | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 m... | Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substa... | Class III | VistaPharm, Inc. |
| 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 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 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 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 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 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 | 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 | 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 | Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, B... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 11, 2017 | Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-cou... | Failed Impurities/Degradation Specifications:Out of specification results for individual unknown ... | Class III | PD-Rx Pharmaceuticals, Inc. |
| 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 | 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 | Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentratio... | 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 | Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentr... | 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 | Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg p... | Presence of Foreign Substance: customer complaint of blue foreign material identified as a portio... | Class II | Morton Grove Pharmaceuticals, Inc. |
| Aug 10, 2017 | Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Inj... | Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds c... | Class II | Premier Pharmacy Labs Inc |
| Aug 10, 2017 | Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. Th... | 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 | Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. T... | 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 | Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mc... | 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 | Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentrati... | 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 | Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/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 | 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... |
| Aug 7, 2017 | Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged fo... | Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with B... | Class I | International Laboratories, 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.