Browse Drug Recalls
14,449 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,449 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 14,449 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 9, 2026 | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... | Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the pa... | Class II | CareFusion 213, LLC |
| Jul 8, 2026 | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bott... | Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications | Class II | Ascend Laboratories, LLC |
| Jul 6, 2026 | CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Sing... | Lack of Assurance of Sterility | Class II | Chiesi USA, Inc. |
| Jul 2, 2026 | Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 via... | Presence of precipitate | Class II | MYLAN PHARMACEUTICALS INC |
| 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 | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, ... | Presence of Foreign Tablets/Capsules | Class II | Bionpharma 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 25, 2026 | Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-0... | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Class II | Bell Pharmaceuticals, Inc |
| 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 | 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 |
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.