Browse Drug Recalls
522 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 522 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 522 FDA drug recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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 4, 2026 | Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels... | Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machin... | Class I | Haleon US Holdings LLC |
| Jun 3, 2026 | Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured ... | Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetac... | Class III | Amneal Pharmaceuticals, LLC |
| Jun 2, 2026 | hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx... | Presence of foreign substance | Class III | ANI Pharmaceuticals, 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 |
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.