U.S. Food and Drug Administration

360 records since March 12, 2026, newest first.

• Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods Oct 13, 2026 · Federal rule (Federal Register)
• FDA Class II: SHANTOU Qiwei industrial Co., Ltd — MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Sep 30, 2026 · FDA enforcement report entry
• FDA Class II: Sterling Pharmaceutical Services LLC — Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Relia Sep 30, 2026 · FDA enforcement report entry
• FDA Class II: Sterling Pharmaceutical Services LLC — Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 Sep 30, 2026 · FDA enforcement report entry
• FDA Class II: Sterling Pharmaceutical Services LLC — Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pha Sep 30, 2026 · FDA enforcement report entry
• FDA Class II: Amneal Pharmaceuticals of New York, LLC — Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Sep 30, 2026 · FDA enforcement report entry
• FDA Class II: Sterling Pharmaceutical Services LLC — Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distrib Sep 30, 2026 · FDA enforcement report entry
• FDA Class II: Sterling Pharmaceutical Services LLC — Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ Sep 30, 2026 · FDA enforcement report entry
• FDA Class II: Sterling Pharmaceutical Services LLC — Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 Sep 30, 2026 · FDA enforcement report entry
• FDA Class II: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company — Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydroch Sep 30, 2026 · FDA enforcement report entry
• FDA Class II: Sterling Pharmaceutical Services LLC — AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL Sep 30, 2026 · FDA enforcement report entry
• FDA Class II: Sterling Pharmaceutical Services LLC — TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Steril Sep 30, 2026 · FDA enforcement report entry
• FDA Class I: B BRAUN MEDICAL INC — 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only Sep 16, 2026 · FDA enforcement report entry
• FDA Class I: American Regent, Inc. — Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Sep 16, 2026 · FDA enforcement report entry
• FDA Class II: OurPharma LLC — fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma Sep 16, 2026 · FDA enforcement report entry
• FDA Class II: Pfizer — Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distri Sep 23, 2026 · FDA enforcement report entry
• FDA Class II: Inventia Healthcare Limited — Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healt Sep 23, 2026 · FDA enforcement report entry
• FDA Class II: SUN PHARMA /TARO — Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc. Sep 23, 2026 · FDA enforcement report entry
• FDA Class II: Safecor Health, LLC — Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volu Sep 23, 2026 · FDA enforcement report entry
• FDA Class II: Safecor Health, LLC — Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volum Sep 23, 2026 · FDA enforcement report entry
• FDA Class II: Safecor Health, LLC — Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volu Sep 23, 2026 · FDA enforcement report entry
• FDA Class I: VITRUVIAS THERAPEUTICS INC — Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyroni Sep 23, 2026 · FDA enforcement report entry
• FDA Class II: Safecor Health, LLC — Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volu Sep 23, 2026 · FDA enforcement report entry
• FDA Class II: Safecor Health, LLC — Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volu Sep 23, 2026 · FDA enforcement report entry
• FDA Class II: Safecor Health, LLC — Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volu Sep 23, 2026 · FDA enforcement report entry
• FDA Class I: Baxter Healthcare Corporation — 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxte Sep 9, 2026 · FDA enforcement report entry
• FDA Class I: OPTIMAL BALANCE PHARMACY — Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid Sep 9, 2026 · FDA enforcement report entry
• FDA Class I: Baxter Healthcare Corporation — Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 6 Sep 16, 2026 · FDA enforcement report entry
• FDA Class II: Baxter Healthcare Corporation — MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, B Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Lexia LLC — Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, Hemp Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Baxter Healthcare Corporation — Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Conta Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Baxter Healthcare Corporation — Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Ga Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Baxter Healthcare Corporation — Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Co Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Baxter Healthcare Corporation — Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonp Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Baxter Healthcare Corporation — Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL S Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Lexia LLC — Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed o Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Baxter Healthcare Corporation — Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Allies Group Inc. — THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5 Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Teva Pharmaceuticals USA, Inc — traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Baxter Healthcare Corporation — CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/m Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Baxter Healthcare Corporation — Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 10 Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Baxter Healthcare Corporation — Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dos Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Baxter Healthcare Corporation — Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Co Sep 9, 2026 · FDA enforcement report entry
• FDA Class II: Apotex Corp. — Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: A Sep 2, 2026 · FDA enforcement report entry
• FDA Class II: ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for Sep 2, 2026 · FDA enforcement report entry
• FDA Class II: ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Sep 2, 2026 · FDA enforcement report entry
• FDA Class II: ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451- Sep 2, 2026 · FDA enforcement report entry
• FDA Class I: B BRAUN MEDICAL INC — Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Be Sep 2, 2026 · FDA enforcement report entry
• FDA Class I: Fresenius Kabi USA, LLC — Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Sep 2, 2026 · FDA enforcement report entry
• FDA Class II: ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-45 Sep 2, 2026 · FDA enforcement report entry