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
Jun 25, 2026 GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - ... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 25, 2026 AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Was... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 25, 2026 TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BU... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 25, 2026 CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 25, 2026 meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 25, 2026 CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 25, 2026 FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bul... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 25, 2026 LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYR... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 25, 2026 Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x ... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 25, 2026 QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bu... SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Class II Bell Pharmaceuticals, Inc
Jun 24, 2026 Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by:... Cross Contamination with Other Products: Customer complaints for appearance of discolored tablet... Class I JB Chemicals and Pharmaceuticals Ltd
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 23, 2026 Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g ... Subpotent Drug: Low out of specification assay results performed during long-term stability testing. Class II Padagis US LLC
Jun 23, 2026 Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg p... CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long... Class II Lupin Pharmaceuticals Inc.
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 Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, ... Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment in... Class II McKesson
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.

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.