Browse Drug Recalls
1,198 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,198 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 1,198 FDA drug recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 18, 2016 | Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe, FOR SUBCUTANE... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 12, 2016 | SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC... | Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets. | Class III | Mckesson Packaging Services |
| Apr 12, 2016 | Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium... | Discoloration: presence of atypical yellow discoloration of the solution . | Class II | Baxter Healthcare Corp. |
| Apr 8, 2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged ... | Failed Impurities/Degradation Specifications: high out of specification results for one of the kn... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Apr 8, 2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged ... | Failed Impurities/Degradation Specifications: high out of specification results for one of the kn... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Apr 8, 2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged ... | Failed Impurities/Degradation Specifications: high out of specification results for one of the kn... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Apr 7, 2016 | Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 ... | Presence of Particulate Matter | Class II | Akorn, Inc. |
| Apr 7, 2016 | Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi... | Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of... | Class III | Fresenius Kabi USA, LLC |
| Apr 6, 2016 | Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for:... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin Pharmaceuticals Inc. |
| Apr 6, 2016 | Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-51... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin Pharmaceuticals Inc. |
| Apr 5, 2016 | Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intraven... | Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Pres... | Class II | Fresenius Kabi USA, LLC |
| Apr 4, 2016 | Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-c... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin Pharmaceuticals Inc. |
| Apr 4, 2016 | BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. ... | Microbial Contamination of Non-Sterile Products: Failed S.aureus test. | Class II | Keystone Laboratories Inc |
| Apr 2, 2016 | Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, ... | Non-sterility - presence of bacteria confirmed by outside laboratory after day 14. | Class I | Complete Pharmacy and Medical Solutions LLC |
| Mar 31, 2016 | LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufacture... | Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033 | Class II | Invisiblu International LLC |
| Mar 31, 2016 | Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Bliste... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Amerisource Health Services |
| Mar 31, 2016 | Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs ... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Amerisource Health Services |
| Mar 31, 2016 | Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons,... | Failed Dissolution Specifications | Class III | Purdue Pharma L.P. |
| Mar 31, 2016 | ¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professio... | Subpotent Drug | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Mar 30, 2016 | PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe,... | Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case... | Class I | QuVa Pharma, Inc. |
| Mar 30, 2016 | Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr... | Failed Impurities/Degradation Specifications; 12 month stability time point | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 25, 2016 | All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All spironolactone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE CO... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All triamcinolone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All Jack Newman Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All sulfapyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All betamethasone diproprionate Products, Rx Only, Compounded by RELIABLE DRU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All fluoxymesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE C... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All cocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDI... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All lidocaine, meloxicam, diclofenac and baclofen Products, Rx Only, Compound... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All nifedipine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All hydroxyzine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All minocycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All quinacrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All melatonin Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUN... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All mirtazapine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All hydrocortisone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE CO... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All retinoic acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All hydroxyurea Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All T4-levothyroxine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE ... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All testosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All citalopram Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All Midrin (isometheptene mucate, dichloralphenazone and acetaminophen) Produ... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All diltiazem Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUN... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All Peterson Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE CO... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All thyroid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDI... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
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.