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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

1,702 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,702 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 1,702 FDA drug recalls, Class III.

Clear
DateProductReasonClassFirm
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 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 Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68... Defective delivery system; product is not foaming or is coming out as liquid. Class III Glenmark Pharmaceuticals Inc., USA
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.
Nov 15, 2019 Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100... Defective delivery system; product is not foaming or is coming out as liquid. Class III Glenmark Pharmaceuticals Inc., USA
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 11, 2019 Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL S... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL S... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 1, 2019 Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufact... Presence of Foreign substance: identified as a dead ant. Class III Lupin Pharmaceuticals Inc.
Nov 1, 2019 Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (ND... Presence of Foreign substance: identified as a dead ant. Class III Lupin Pharmaceuticals Inc.
Nov 1, 2019 Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manuf... Presence of Foreign substance: identified as a dead ant. Class III Lupin Pharmaceuticals Inc.
Oct 22, 2019 Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manuf... Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Ato... Class III Apotex 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 Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx... 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 Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to th... Labeling: Incorrect or missing package insert. Class III Sandoz Inc
Oct 16, 2019 Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10... Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. Class III Amneal Pharmaceuticals, 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 4, 2019 Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar... Presence of Foreign Substance; Fiber particles. Class III KVK-Tech, Inc.
Oct 1, 2019 Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distribute... Subpotent Drug Class III Sato Pharmaceutical 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.
Oct 1, 2019 WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (... Subpotent Drug Class III Sato Pharmaceutical Inc.
Oct 1, 2019 Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distri... Subpotent Drug Class III Sato Pharmaceutical Inc.
Oct 1, 2019 Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, D... Subpotent Drug 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 24, 2019 Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by... Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle Class III Amneal Pharmaceuticals, Inc.
Sep 23, 2019 Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp,... CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles... Class III AuroMedics Pharma 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 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 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 6, 2019 Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: ... Failed Impurities/Degradation Specifications:OOS for unknown impurity. Class III Mylan Pharmaceuticals Inc.
Sep 6, 2019 Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 coun... GMP Deviation: lot not intended for commercial distribution. Class III Teva Pharmaceuticals USA
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 26, 2019 minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physici... Failed Dissolution Specifications: Class III EPI Health, LLC
Aug 21, 2019 Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufa... Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride... Class III Macleods Pharma Usa Inc
Aug 7, 2019 Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tube... Temperature Abuse: Complaints received of liquidy texture. Class III Glenmark Pharmaceuticals Inc., USA
Aug 6, 2019 Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, Fo... Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-as... Class III Akorn, Inc.
Aug 6, 2019 Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, Fo... Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) an... Class III Akorn, Inc.
Aug 6, 2019 Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 1... Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-as... Class III Akorn, 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 18, 2019 Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) ... Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergono... Class III Amneal Pharmaceuticals, Inc.
Jul 17, 2019 Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tub... Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of c... Class III Lupin Pharmaceuticals 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 17, 2019 Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g bo... Failed Stability Specifications: Out of specification for viscosity. Class III Bausch & Lomb
Jun 12, 2019 Testosterone Topical Solution 30mg of testosterone per pump actuation * each ... Defective Container; actuator may improperly function and affect dose delivery. Class III InvaGen Pharmaceuticals, 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 22, 2019 Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kab... Failed Impurities/Degradation Specifications. Class III Fresenius Kabi USA, LLC
May 20, 2019 Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC ... Failed Impurities/Degradation Specifications Class III Teligent Pharma, 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.