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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

2,021 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,021 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 2,021 FDA drug recalls.

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DateProductReasonClassFirm
Dec 18, 2019 Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Naltrexone 4.5 mg capsule Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Tadalafil 6 mg Capsule Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Progesterone 200 mg Troche Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Squaric Acid 0.1% Topical Solution (Clinic) 30 mL Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Nov 27, 2019 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only,... Labeling: Incorrect or Missing Lot and/or expiration date. Class II Pfizer Inc.
Nov 20, 2019 SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 20, 2019 SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deod... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 20, 2019 Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by... Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo... Class I AuroMedics Pharma LLC
Nov 20, 2019 SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net W... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 20, 2019 Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by:... Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo... Class I AuroMedics Pharma LLC
Nov 20, 2019 SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, ... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 15, 2019 Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist... Labeling mix-up - Indications on product label are incorrect. Class III Grato Holdings, Inc.
Nov 15, 2019 Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topi... Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... Class III Rising Pharmaceuticals, Inc.
Nov 15, 2019 MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3... Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP ... Class II Akorn, Inc.
Nov 15, 2019 Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For T... Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... Class III Rising Pharmaceuticals, Inc.
Oct 21, 2019 PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, ... Incorrect labeling: Incorrect or missing lot and/or exp date Class III Nephron Pharmaceuticals Corporation dba Nephron...
Oct 17, 2019 Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to th... Labeling: Incorrect or missing package insert. Class III Sandoz Inc
Oct 17, 2019 Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste... Labeling: Incorrect or missing package insert. Class III Sandoz Inc
Oct 17, 2019 Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx... Labeling: Incorrect or missing package insert. Class III Sandoz Inc
Oct 11, 2019 Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manuf... Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached. Class III X-Gen Pharmaceuticals Inc.
Oct 1, 2019 Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) ... Subpotent Drug: Formulated amount of sennosides component is less than labelled claim. Class III Sato Pharmaceutical Inc.
Sep 27, 2019 Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose,... Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1... Class III Arbor Pharmaceuticals Inc.
Sep 26, 2019 Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial.... Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed ... Class II Alkermes, Inc.
Sep 13, 2019 Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, pac... Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syring... Class II GUERBET LLC
Sep 13, 2019 Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefille... Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syring... Class III GUERBET LLC
Sep 12, 2019 ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by... Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco... Class III Pfizer Inc.
Sep 12, 2019 Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made... Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco... Class III Pfizer Inc.
Sep 6, 2019 Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For... Temperature Abuse; Product stored and shipped outside of labeled storage requirements. Class II Cardinal Health dba Specialty Pharmaceutical Se...
Sep 6, 2019 Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g N... Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified a... Class I Darmerica, LLC
Aug 28, 2019 Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Sou... Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product i... Class II Atlas Pharmaceuticals, LLC
Aug 27, 2019 Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, N... Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths secti... Class III American Health Packaging
Aug 8, 2019 Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial.... Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed... Class II Alkermes Inc
Jul 29, 2019 Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: A... Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054... Class III Aurobindo Pharma USA Inc.
Jul 15, 2019 LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, ... Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling o... Class II La Fresh Group, Inc.
Jul 11, 2019 Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste... Labeling: Missing label; Product complaints reported missing bottle label. Class III Lupin Pharmaceuticals Inc.
Jun 25, 2019 Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count U... Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration da... Class III AAA Pharmaceutical, Inc.
Jun 7, 2019 Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsu... Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primar... Class III Akorn Inc
May 28, 2019 Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredient... Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage informat... Class I Novis PR, Inc.
May 13, 2019 Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactur... Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were fo... Class II MALLINCKRODT PHARMACEUTICALS
May 13, 2019 Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufacture... Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were fo... Class II MALLINCKRODT PHARMACEUTICALS
May 2, 2019 Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 c... Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printe... Class II Septodont Inc.
Apr 29, 2019 Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per ... Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax... Class III Pfizer Inc.
Apr 25, 2019 Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by:... Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg act... Class II Zydus Pharmaceuticals USA Inc
Apr 25, 2019 Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 2... Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the n... Class III Advantice Health
Apr 25, 2019 Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 2... Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rathe... Class III Advantice Health
Apr 25, 2019 Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: C... Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg act... Class II Zydus Pharmaceuticals USA Inc
Apr 22, 2019 ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Fo... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE San... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) ... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd

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.