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 |
|---|---|---|---|---|
| Jul 26, 2016 | Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hatties... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostagla... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, H... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, M... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, cl... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, ... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial,... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hat... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 19, 2016 | Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 6... | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Class II | Zydus Pharmaceuticals USA Inc |
| Jul 19, 2016 | Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68... | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Class II | Zydus Pharmaceuticals USA Inc |
| Jul 19, 2016 | Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogena... | Lack of Assurance of Sterility | Class II | Talon Compounding Pharmacy |
| Jul 18, 2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoS... | Penicillin Cross Contamination | Class II | GlaxoSmithKline, LLC |
| Jul 18, 2016 | Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmi... | Penicillin Cross Contamination | Class II | GlaxoSmithKline, LLC |
| Jul 18, 2016 | Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx... | Penicillin Cross Contamination | Class II | GlaxoSmithKline, LLC |
| Jul 18, 2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSm... | Penicillin Cross Contamination | Class II | GlaxoSmithKline, LLC |
| Jul 12, 2016 | Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pac... | Superpotent Drug: Failure of assay specifications in the capsule. | Class II | Supernus Pharmaceuticals, Inc. |
| Jul 11, 2016 | Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles... | Failed Dissolution Specifications | Class II | Actavis Inc |
| Jul 7, 2016 | Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count ... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W... | Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile envir... | Class II | Medicap Pharmacy |
| Jul 7, 2016 | Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, ... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor He... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Heal... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor He... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 5, 2016 | Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chlorid... | Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant cl... | Class II | Let's Talk Health, Inc. |
| Jul 1, 2016 | Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Class II | Dream Body Weight Loss |
| Jul 1, 2016 | Dream Body Advanced 400 mg 30 capsules in brown foil packets. | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Class II | Dream Body Weight Loss |
| Jul 1, 2016 | Dream Body 450 mg 30 capsules in a plastic screw on top bottle | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Class II | Dream Body Weight Loss |
| Jun 30, 2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for O... | Failed Content Uniformity Specifications | Class II | Allergan Sales, LLC |
| Jun 30, 2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional ... | Failed Content Uniformity Specifications | Class II | Allergan Sales, LLC |
| Jun 30, 2016 | Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufact... | Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specificati... | Class II | Actavis Inc |
| Jun 29, 2016 | Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multi... | Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action f... | Class II | Isomeric Pharmacy Solution, LLC |
| Jun 29, 2016 | TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial... | Class II | Vital Care Compounder, LLC |
| Jun 24, 2016 | Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Man... | Superpotent drug: Out of specification test result for assay during stability testing. | Class II | Teva North America |
| Jun 23, 2016 | Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake ... | Crystallization: Product contains particulate identified to be crystallized active ingredient. | Class II | Hospira Inc. |
| Jun 22, 2016 | Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in ... | Presence of Foreign Substance; presence of black particles describes generically as cellulose-bas... | Class II | Teva North America |
| Jun 22, 2016 | Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Ma... | Failed Dissolution Specifications | Class II | Mylan Pharmaceuticals Inc. |
| Jun 20, 2016 | Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A... | Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... | Class II | W & C dba The Apothecary |
| Jun 20, 2016 | Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A... | Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... | Class II | W & C dba The Apothecary |
| Jun 20, 2016 | Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS... | Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... | Class II | W & C dba The Apothecary |
| Jun 20, 2016 | Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE... | Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... | Class II | W & C dba The Apothecary |
| Jun 20, 2016 | Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY,... | Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... | Class II | W & C dba The Apothecary |
| Jun 17, 2016 | Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hun... | CGMP Deviations | Class II | Teva North America |
| Jun 17, 2016 | ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Onl... | CGMP Deviations | Class II | Teva North America |
| Jun 17, 2016 | Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA P... | CGMP Deviations | Class II | Teva North America |
| Jun 17, 2016 | Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intrave... | CGMP Deviations | Class II | Teva North America |
| Jun 13, 2016 | Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - ... | Presence of Particulate Matter; The firm received two product complaints for small, dark particul... | Class II | Sagent Pharmaceuticals 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.