Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Jun 29, 2026 Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactur... cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Cipla USA, Inc.
Jun 29, 2026 Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactur... cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Cipla USA, Inc.
Jun 29, 2026 Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactur... cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Cipla USA, Inc.
Jun 26, 2026 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER ... Class II Lannett Company Inc.
Jun 24, 2026 Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, C... Failed Impurities/Degradation Specifications Class II QuVa Pharma, Inc.
Jun 24, 2026 Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, Fo... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 24, 2026 Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 24, 2026 Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intraven... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 24, 2026 Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 22, 2026 DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Direct Rx
Jun 17, 2026 Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutica... Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 16, 2026 Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLET... Subpotent Drug Class II The Harvard Drug Group LLC
Jun 12, 2026 Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-relea... CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed... Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Jun 12, 2026 Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per... Crystallization; identified as Buprenorphine free base Class II Par Health USA, LLC
Jun 11, 2026 Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Me... Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. Class II BioMed Laboratories, LLC.
Jun 11, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopr... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v i... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropy... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v i... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v is... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 10, 2026 IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Singl... Lack of assurance of Sterility: Class II ACCORD BIOPHARMA INC
Jun 8, 2026 Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only,... Lack of Assurance of Sterility Class II Asclemed USA Inc.
Jun 8, 2026 Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx on... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Jun 8, 2026 Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL sin... Lack of Assurance of Sterility Class II Asclemed USA Inc.
Jun 7, 2026 Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Ma... Failed Impurities/Degradation Specifications Class II ONESOURCE SPECIALTY PHARMA LIMITED
Jun 5, 2026 Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only,... Failed Dissolution Specifications Class II Inventia Healthcare Limited
Jun 4, 2026 prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 m... Presence of Foreign Substance Class II Lupin Pharmaceuticals Inc.
Jun 4, 2026 Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed b... CGMP Deviations Class II Amgen, Inc.
Jun 4, 2026 Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed b... CGMP Deviations Class II Amgen, Inc.
Jun 4, 2026 Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care,... sub potency Class II Elevate Oral Care
Jun 4, 2026 Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed b... CGMP Deviations Class II Amgen, Inc.
Jun 4, 2026 Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 5... Presence of Foreign Substance. Class II Amgen, Inc.
Jun 4, 2026 Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., ... Presence of Foreign Substance. Class II Amgen, Inc.
Jun 4, 2026 Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pha... Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet i... Class II Annora Pharma Private Limited
Jun 4, 2026 Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc.
Jun 4, 2026 Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (N... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc.
Jun 2, 2026 Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient sp... Incorrect product formulation: bag did not contain copper and famotidine per label. Class II Central Admixture Pharmacy Services, Inc.
Jun 2, 2026 Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin S... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Su... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufacture... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neom... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactur... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured f... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited

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.