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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

Consumer Safety

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

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Dec 18, 2019 Sildenafil 80 mg capsules 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 E4M SR 100 mg capsules 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 Testosterone Topical Cream 4% 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 Finasteride/Biotin 1 mg/50 mcg 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 Magic Bullet Supplement 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 Sildenafil 200 mg Troche (Clinic) 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 50 mg capsules 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 Liothyronine (T3) 92.5 MCG 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 DHEA/Pregnenol One 10.25 MG Cap 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 20 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 T3/T4 SR 9 mcg/38 mcg 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 Liothyronine (T3) 80 mcg SR cap Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 17, 2019 Stallion Platinum 30000 Capsules in blue,orange,white background with red,whi... Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil Class I Motto International Corp
Dec 17, 2019 Panther Platinum 30000 Capsules, in green, black background with white, red t... Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil Class I Motto International Corp
Dec 17, 2019 Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose ... Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) Class I Hikma Pharmaceuticals USA Inc.
Dec 17, 2019 Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Gl... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background wi... Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil Class I Motto International Corp
Dec 17, 2019 Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Gl... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) Class II Hikma Pharmaceuticals USA Inc.
Dec 17, 2019 Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,whi... Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil Class I Motto International Corp
Dec 16, 2019 NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 ... Subpotent Drug Class III Pharmedium Services, LLC
Dec 16, 2019 NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 ... Subpotent Drug Class III Pharmedium Services, LLC
Dec 16, 2019 Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx o... Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of th... Class II Akorn Inc
Dec 16, 2019 NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 ... Subpotent Drug Class III Pharmedium Services, LLC
Dec 13, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III The Harvard Drug Group
Dec 13, 2019 RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA ND... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Granules India Limited
Dec 13, 2019 Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx... Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other i... Class III Lupin Pharmaceuticals Inc.
Dec 11, 2019 Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repac... CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts a... Class II RemedyRepack Inc.
Dec 11, 2019 Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronize... Subpotent Drug: Supplier indicated assay results did not meet specifications. Class II Spectrum Laboratory Products
Dec 10, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-co... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III Lupin Pharmaceuticals Inc.
Dec 9, 2019 Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals,... Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impur... Class II Asclemed USA Inc. dba Enovachem Pharmaceuticals
Dec 9, 2019 Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals,... Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impur... Class II Asclemed USA Inc. dba Enovachem Pharmaceuticals
Dec 9, 2019 Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals,... Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impur... Class II Asclemed USA Inc. dba Enovachem Pharmaceuticals
Dec 6, 2019 Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, D... Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total ... Class I Lannett Company, Inc.
Dec 4, 2019 Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister card... Failed Dissolution Specifications: Low out of specification results obtained during stability tes... Class II American Health Packaging
Dec 2, 2019 Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For... Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution. Class III AuroMedics Pharma LLC
Dec 2, 2019 Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufact... Presence of Foreign Substance: Presence of a foreign object in a single tablet. Class II Jubilant Cadista Pharmaceuticals, Inc.
Dec 2, 2019 Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03),... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Preferred Pharmaceuticals, Inc
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 26, 2019 Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road... Presence of Foreign Substance: Foreign material found inside the vial (manufacturer). Class II SCA Pharmaceuticals, LLC
Nov 25, 2019 Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-co... Discoloration: Product complaints of discoloration after reconstitution of vials. Class II AuroMedics Pharma LLC
Nov 25, 2019 VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 ... Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the pro... Class III Apothecus Pharmaceutical Corp.
Nov 25, 2019 Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 11... Cross contamination with other products: undeclared contaminants of phenol and camphor in petrole... Class II OraLabs, Incorporated
Nov 25, 2019 Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Pa... Failed Impurities/Degradation Specifications Class II Medisca, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).1... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, 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.