Browse Drug Recalls

633 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 633 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 633 FDA drug recalls in 2026.

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DateProductReasonClassFirm
Sep 10, 2026 BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodi... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity ... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 9... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosa... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosag... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, tota... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosa... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosa... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosa... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dos... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use do... Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II Carolina Infusion, LLC
Sep 10, 2026 Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dos... Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II Carolina Infusion, LLC
Sep 10, 2026 Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use do... Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II Carolina Infusion, LLC
Sep 10, 2026 Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use do... Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II Carolina Infusion, LLC
Sep 10, 2026 TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosa... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage... Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II Carolina Infusion, LLC
Sep 8, 2026 Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Do... Crystallization Class II Par Health USA, LLC
Sep 8, 2026 Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by:... Defective Container; packets were found to be either empty or partially full. Class II Amneal Pharmaceuticals, LLC
Sep 4, 2026 Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials pe... Lack of Assurance of Sterility Class II Pfizer
Sep 3, 2026 Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufact... Failed Dissolution Specifications Class II Inventia Healthcare Limited
Sep 3, 2026 fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0... Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of... Class II OurPharma LLC
Sep 1, 2026 Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Labor... Microbial contamination of topical product. Class II SV Labs Toronto Corporation
Sep 1, 2026 Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0... Microbial contamination of topical product. Class II SV Labs Toronto Corporation
Aug 31, 2026 Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a car... Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor c... Class II TerSera Therapeutics LLC
Aug 31, 2026 Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Tar... Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 2... Class II SUN PHARMA /TARO
Aug 31, 2026 Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx o... Failed dissolution specifications. Class III Supernus Pharmaceuticals, Inc.
Aug 28, 2026 Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subc... Defective Delivery System: Possibility of no medication in the prefilled pen. Class II Amneal Pharmaceuticals of New York, LLC
Aug 27, 2026 Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Mac... Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. Class III Macleods Pharmaceuticals Limited
Aug 26, 2026 Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile,... Failed Dissolution Specifications Class II Mylan Pharmaceuticals Inc
Aug 25, 2026 Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Ma... Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) d... Class III Ajanta Pharma USA Inc
Aug 24, 2026 Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per ... Subpotent Drug Class III ImprimisRx NJ LLC
Aug 24, 2026 traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactur... Presence of Foreign Tablets/Capsules Class II Teva Pharmaceuticals USA, Inc
Aug 24, 2026 Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) ... Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclo... Class II Hikma Pharmaceuticals USA INC.
Aug 21, 2026 Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine ... Superpotent Drug Class I VITRUVIAS THERAPEUTICS INC
Aug 21, 2026 Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSM... Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled ... Class II Golden State Medical Supply Inc.
Aug 21, 2026 Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (C... CGMP Deviations: Potential contamination of raw material Class II Lexia LLC
Aug 21, 2026 Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Iso... CGMP Deviations: Potential contamination of raw material Class II Lexia LLC
Aug 20, 2026 Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant ... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Di... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 c... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, ... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye ... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye ... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellul... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC

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.