FDA Drug · 2025
FDA Drug recalls in 2025
RecallRadar indexes 765 FDA Drug recall notices published in 2025. By classification: 49 Class I, 655 Class II, 61 Class III.
- HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India…
FDA Drug · Class II · 2025-02-12 · Sky Packaging - Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distribute…
FDA Drug · Class II · 2025-02-12 · The Harvard Drug Group - Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceuti…
FDA Drug · Class I · 2025-02-12 · Endo Usa - HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distribut…
FDA Drug · Class II · 2025-02-12 · Sky Packaging - Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc.,…
FDA Drug · Class III · 2025-02-12 · Pai Holdings - Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05
FDA Drug · Class II · 2025-02-12 · Glenmark Pharmaceuticals Usa - Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by:…
FDA Drug · Class II · 2025-02-05 · Mckesson - Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbro…
FDA Drug · Class I · 2025-02-05 · Astellas Pharma Us - BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route…
FDA Drug · Class III · 2025-02-05 · The W S Badger - Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US…
FDA Drug · Class I · 2025-02-05 · Astellas Pharma Us - Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (1…
FDA Drug · Class II · 2025-02-05 · The Harvard Drug Group - FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250
FDA Drug · Class I · 2025-01-29 · Shoppers Plaza - Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma
FDA Drug · Class III · 2025-01-29 · Appco Pharma - Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 720…
FDA Drug · Class II · 2025-01-29 · Brands International - First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, New…
FDA Drug · Class II · 2025-01-29 · First Aid Beauty - Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc
FDA Drug · Class I · 2025-01-22 · Alcon Research - glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Colu…
FDA Drug · Class II · 2025-01-22 · Amerisource Health Services - Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by:…
FDA Drug · Class II · 2025-01-22 · Amerisource Health Services - Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 070…
FDA Drug · Class III · 2025-01-22 · Akron Pharma - Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-80…
FDA Drug · Class III · 2025-01-22 · Akron Pharma - Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E,…
FDA Drug · Class III · 2025-01-22 · Akron Pharma - Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505…
FDA Drug · Class II · 2025-01-22 · Viatris - Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 11…
FDA Drug · Class III · 2025-01-22 · Akron Pharma - Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite…
FDA Drug · Class III · 2025-01-22 · Akron Pharma - Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505,…
FDA Drug · Class II · 2025-01-22 · Viatris - Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite…
FDA Drug · Class III · 2025-01-22 · Akron Pharma - Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004,…
FDA Drug · Class III · 2025-01-22 · Akron Pharma - Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08…
FDA Drug · Class II · 2025-01-15 · Eugia Us - Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfie…
FDA Drug · Class II · 2025-01-15 · Fdc - Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each),…
FDA Drug · Class I · 2025-01-15 · Endo Usa - Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles
FDA Drug · Class II · 2025-01-15 · Rising Pharma Holding - Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia
FDA Drug · Class I · 2025-01-15 · Buy Herbal - Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distr…
FDA Drug · Class I · 2025-01-15 · Endo Usa - Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each),…
FDA Drug · Class I · 2025-01-15 · Endo Usa - Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by:…
FDA Drug · Class II · 2025-01-15 · Amerisource Health Services - Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc
FDA Drug · Class II · 2025-01-15 · Granules Pharmaceuticals - Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hydera…
FDA Drug · Class II · 2025-01-15 · Granules Pharmaceuticals - medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08…
FDA Drug · Class II · 2025-01-15 · Eugia Us - Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured fo…
FDA Drug · Class II · 2025-01-15 · Jubilant Draximage - Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ N…
FDA Drug · Class II · 2025-01-15 · Rising Pharma Holding - Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Dis…
FDA Drug · Class I · 2025-01-15 · Endo Usa - Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heigh…
FDA Drug · Class III · 2025-01-15 · West Ward Columbus - Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distri…
FDA Drug · Class II · 2025-01-15 · Rising Pharma Holding - ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road,…
FDA Drug · Class II · 2025-01-08 · Hikma Injectables Usa - Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE,…
FDA Drug · Class III · 2025-01-08 · Avkare - FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles
FDA Drug · Class I · 2025-01-08 · Gnmart - Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., C…
FDA Drug · Class II · 2025-01-08 · Viona Pharmaceuticals - Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC…
FDA Drug · Class III · 2025-01-08 · Somerset Therapeutics - Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478
FDA Drug · Class II · 2025-01-08 · Avkare - phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 0881…
FDA Drug · Class II · 2025-01-08 · Hikma Injectables Usa - Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc
FDA Drug · Class II · 2025-01-08 · Lupin Pharmaceuticals - Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cr…
FDA Drug · Class II · 2025-01-08 · Viona Pharmaceuticals - Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN…
FDA Drug · Class III · 2025-01-08 · Avkare - Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, In…
FDA Drug · Class II · 2025-01-01 · Amerisource Health Services - Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each conta…
FDA Drug · Class II · 2025-01-01 · Curium Us - chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ
FDA Drug · Class II · 2025-01-01 · Glenmark Pharmaceuticals Usa - Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Mar…
FDA Drug · Class II · 2025-01-01 · Breckenridge Pharmaceutical - Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only…
FDA Drug · Class II · 2025-01-01 · Remedyrepack - Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090…
FDA Drug · Class II · 2025-01-01 · Amerisource Health Services - Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, I…
FDA Drug · Class II · 2025-01-01 · Amerisource Health Services - Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Mart…
FDA Drug · Class II · 2025-01-01 · Breckenridge Pharmaceutical - DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
FDA Drug · Class II · 2025-01-01 · Pd Rx Pharmaceuticals - Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, In…
FDA Drug · Class II · 2025-01-01 · Amerisource Health Services - UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
FDA Drug · Class II · 2025-01-01 · Mxbbb - chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ
FDA Drug · Class II · 2025-01-01 · Glenmark Pharmaceuticals Usa
Other years
2026 (565) · 2025 (765) · 2024 (657) · 2023 (1,252) · 2022 (1,349) · 2021 (1,016) · 2020 (1,035) · 2019 (2,152) · 2018 (1,426) · 2017 (1,073) · 2016 (1,254) · 2015 (2,020) · 2014 (1,562) · 2013 (1,377) · 2012 (434)