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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.

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DateProductReasonClassFirm
Feb 2, 2017 Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (N... Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stat... Class II Sandoz Inc
Feb 2, 2017 Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Cover... Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Ca... Class III Sage Products Inc
Jan 30, 2017 Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 bli... Chemical Contamination: out of specification results for impurities were found to be the result o... Class III Mylan Pharmaceuticals Inc.
Jan 30, 2017 Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufa... Failed Dissolution Specifications. Above out of specification for dissolution rate observed at th... Class II Actavis Inc
Jan 30, 2017 Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and ... Chemical Contamination: out of specification results for impurities were found to be the result o... Class III Mylan Pharmaceuticals Inc.
Jan 27, 2017 MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxid... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMI... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 ... Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of... Class III Pharmedium Services, LLC
Jan 27, 2017 MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) t... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. (35 g) tube, Mad... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 ... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactur... Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 24, 2017 Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package ... Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. Th... Class I Hospira Inc., A Pfizer Company
Jan 19, 2017 Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bo... Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle Class II Mylan Pharmaceuticals Inc.
Jan 19, 2017 glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan ... Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 ... Class II Mylan Pharmaceuticals Inc.
Jan 19, 2017 Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) ... Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized... Class II LEO PHARMA INC
Jan 18, 2017 Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL pe... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx o... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx o... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 ... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottl... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per ca... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15... Defective Container: Leakage of unit dose cups that may occur at the seal. Class II VistaPharm, Inc.
Jan 18, 2017 Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose ... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 l... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (3... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 ... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 16, 2017 Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, ... Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-... Class III LEO PHARMA INC
Jan 16, 2017 DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for:... Failed Impurities/ Degradation Specifications Class III Vintage Pharmaceuticals LLC dba Qualitest Pharm...
Jan 13, 2017 Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 ... Failed Stability Specifications: confirmed out of specification results obtained during refrigera... Class II AbbVie Inc.
Jan 12, 2017 Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vial... Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. Class III Actavis Inc
Jan 12, 2017 Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottl... Failed Dissolution Specifications Class II Sun Pharmaceutical Industries, Inc.
Jan 9, 2017 Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr... Defective Container: Product complaints received of defect in the seal of the Docetaxel injection... Class II Dr. Reddy's Laboratories, Inc.
Jan 7, 2017 Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for... Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue ... Class III Hetero USA Inc
Jan 5, 2017 Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, ... Subpotent Class III InnovaGel
Jan 5, 2017 Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swi... Subpotent Class III InnovaGel
Jan 5, 2017 Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufa... Failed Dissolution Specifications Class II The Harvard Drug Group
Jan 5, 2017 Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufa... Failed Dissolution Specifications Class II The Harvard Drug Group
Jan 5, 2017 Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, R... Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet ident... Class II Sun Pharmaceutical Industries, Inc.
Jan 4, 2017 Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 ... Supotent: Out of Specification result for assay test during routine stability testing. Class III Mckesson Packaging Services

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.