Class III drugs recalls
FDA Class III recalls of drugs, newest first. Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
120 recalls published between October 9, 2024 and September 30, 2026. Most common issues: potency (17), microbial contamination (12).
- Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only… recall
- Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only… recall
- Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution… recall
- Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10)… recall
- Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL)… recall
- Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules… recall
- Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10… recall
- Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag… recall
- Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further… recall
- Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further… recall
- Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack… recall
- Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules… recall
- Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only… recall
- Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only… recall
- Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial… recall
- Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine… recall
- hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint)… recall
- Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per… recall
- Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only… recall
- Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only… recall
- Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL)… recall
- PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL… recall
- Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva… recall
- Busulfan Injection, 60 mg per 10 mL (6 mg per mL)… recall
- Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per… recall
- Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister)… recall
- Primidone Tablets, USP, 250 mg, 100-count bottle, RX only… recall
- Primidone Tablets, USP, 50 mg, 50-count bottle, RX only… recall
- Primidone Tablets USP, 250mg, 100-count bottle, Rx only… recall
- busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only… recall
- Lidocaine Wound Gel (Benzalkonium Chloride… recall
- Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial… recall
- Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only… recall
- Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle… recall
- Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt recall
- Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%… recall
- Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle… recall
- Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing… recall
- Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only… recall
- Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only… recall
- Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only… recall
- Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus… recall
- Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only… recall
- Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz recall
- parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint recall
- Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz)… recall
- Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution… recall
- Fluocinolone Acetonide Solution Topical Solution USP, 0.01%… recall
- Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets… recall
- traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only… recall
- Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL)… recall
- Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL)… recall
- Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL)… recall
- Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL… recall
- Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only… recall
- Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr recall
- Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg… recall
- Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII… recall
- Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic… recall
- Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle… recall