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Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

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DateProductReasonClassFirm
Mar 13, 2019 Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactur... Defective Container: Repetitive complaints received indicating pump not working. Class III Lupin Pharmaceuticals Inc.
Mar 13, 2019 Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 3... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, Q... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile singl... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable S... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Soluti... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectabl... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Sol... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Ster... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 12, 2019 Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, ... Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testi... Class II Akorn Inc
Mar 12, 2019 Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Aci... Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. Class II MSM Nutraceuticals, LLC
Mar 12, 2019 Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Aci... Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. Class II MSM Nutraceuticals, LLC
Mar 12, 2019 Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr... Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. Class II MSM Nutraceuticals, LLC
Mar 12, 2019 15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceutic... Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. Class II MSM Nutraceuticals, LLC
Mar 12, 2019 Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx D... CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in th... Class II Direct Rx
Mar 11, 2019 Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx ... Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, there... Class II Iso-Tex Diagnostics, Inc
Mar 11, 2019 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablet... Subpotent Drug. Class III Teva Pharmaceuticals USA
Mar 8, 2019 Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorpo... CGMP deviation: Product found to contain trace amounts of NMBA Class II PD-Rx Pharmaceuticals, Inc.
Mar 7, 2019 Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Ace... CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... Class II Rising Pharmaceuticals, Inc.
Mar 7, 2019 Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tabl... Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stabili... Class III Boehringer Ingelheim Pharmaceuticals, Inc.
Mar 7, 2019 Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Heal... CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... Class II Rising Pharmaceuticals, Inc.
Mar 7, 2019 Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the foll... Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items con... Class II Medtech Products, Inc.
Mar 7, 2019 Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Ace... CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... Class II Rising Pharmaceuticals, Inc.
Mar 7, 2019 Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Ace... CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... Class II Rising Pharmaceuticals, Inc.
Mar 6, 2019 Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, ... CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... Class II American Health Packaging
Mar 6, 2019 Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx onl... Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterilit... Class II Dr. Reddy's Laboratories, Inc.
Mar 6, 2019 Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-0... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified. Class II Preferred Pharmaceuticals, Inc
Mar 5, 2019 LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containi... Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approve... Class I USA LESS Inc.
Mar 5, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tab... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified Class II AVKARE Inc.
Mar 5, 2019 Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx On... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified Class II AVKARE Inc.
Mar 5, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tabl... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified Class II AVKARE Inc.
Mar 4, 2019 ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 ... Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contain... Class III Petra Hygienic Systems Int Ltd
Mar 4, 2019 Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 m... CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found ... Class II H J Harkins Company Inc dba Pharma Pac
Mar 1, 2019 Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distrib... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Class II Legacy Pharmaceutical Packaging LLC
Mar 1, 2019 Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected. Class II Legacy Pharmaceutical Packaging LLC
Mar 1, 2019 Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distribut... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Class II Legacy Pharmaceutical Packaging LLC
Mar 1, 2019 Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Class II Legacy Pharmaceutical Packaging LLC
Mar 1, 2019 Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 4... Failed Dissolution Specifications Class III AVKARE Inc.
Mar 1, 2019 Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules... Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity... Class II American Health Packaging

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.