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 |
|---|---|---|---|---|
| Sep 8, 2017 | AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Pa... | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Class III | AbbVie Inc. |
| Sep 5, 2017 | Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Sali... | Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for ... | Class II | Llorens Pharmaceutical Corp. |
| Sep 5, 2017 | ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhard... | Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lo... | Class III | Aidarex Pharmaceuticals LLC |
| Sep 5, 2017 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. ... | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Steri... | Lack of Assurance of Sterility and cGMP Deviations | Class II | Simple Diagnostics, Inc. |
| Sep 5, 2017 | Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with... | Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials. | Class I | Genentech, Inc. |
| Sep 5, 2017 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz.... | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Ph... | Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is ... | Class II | Teva Pharmaceuticals USA |
| Sep 5, 2017 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz.... | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. ... | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aid... | Failed Impurities/Degradation Specification; out-of-specification results for individual unknown ... | Class III | Aidarex Pharmaceuticals LLC |
| Sep 1, 2017 | Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx On... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL b... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag, Rx Onl... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL b... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx On... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactu... | Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials. | Class II | Pfizer Inc. |
| Sep 1, 2017 | Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx On... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL b... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx O... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 ... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Aug 31, 2017 | Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Si... | Presence of Particulate Matter | Class II | Amneal Pharmaceuticals LLC |
| Aug 30, 2017 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... | Defective Delivery System: Products no longer meet the release liner removal specification and/or... | Class II | Noven Pharmaceuticals, Inc. |
| Aug 30, 2017 | Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.... | Defective Delivery System: Products no longer meet the release liner removal specification and/or... | Class II | Noven Pharmaceuticals, Inc. |
| Aug 30, 2017 | Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephri... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Mid Valley Pharmaceutical |
| Aug 30, 2017 | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.... | Defective Delivery System: Products no longer meet the release liner removal specification and/or... | Class II | Noven Pharmaceuticals, Inc. |
| Aug 30, 2017 | Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.... | Defective Delivery System: Products no longer meet the release liner removal specification and/or... | Class II | Noven Pharmaceuticals, Inc. |
| Aug 30, 2017 | Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only... | Presence of Particulate Matter: glass particulate found in vial | Class I | Pfizer Inc. |
| Aug 30, 2017 | Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochlori... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Mid Valley Pharmaceutical |
| Aug 29, 2017 | Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packag... | Failed Stability Specifications | Class III | Amerisource Health Services |
| Aug 29, 2017 | PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, ... | Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone. | Class I | Lucky Mart Inc. |
| Aug 28, 2017 | Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose card... | Failed moisture limits: Out of specification for moisture content. | Class III | Mckesson Packaging Services |
| Aug 23, 2017 | Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Univer... | GMP Deviations; potential bacterial contamination may have been introduced to products through a ... | Class II | Inopak Ltd |
| Aug 23, 2017 | Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Dis... | GMP Deviations; potential bacterial contamination may have been introduced to products through a ... | Class II | Inopak Ltd |
| Aug 23, 2017 | Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18... | GMP Deviations; potential bacterial contamination may have been introduced to products through a ... | Class II | Inopak Ltd |
| 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 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 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 | 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 | 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 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 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 | 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 | 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 |
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.