FDA Drug · 2023
FDA Drug recalls in 2023
RecallRadar indexes 1,252 FDA Drug recall notices published in 2023. By classification: 67 Class I, 1,096 Class II, 89 Class III.
- NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp
FDA Drug · Class II · 2023-03-15 · Nutraceutical - Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged…
FDA Drug · Class II · 2023-03-15 · Ecometics - Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health P…
FDA Drug · Class II · 2023-03-15 · Amerisource Health Services - Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: Th…
FDA Drug · Class II · 2023-03-15 · Ecometics - Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
FDA Drug · Class II · 2023-03-15 · Denver Solutions - Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO…
FDA Drug · Class II · 2023-03-15 · Denver Solutions - Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distr…
FDA Drug · Class II · 2023-03-15 · Ecometics - DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc
FDA Drug · Class III · 2023-03-15 · Akron Pharma - Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc
FDA Drug · Class II · 2023-03-15 · Ecometics - Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham,…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare, Inc
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Int…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per car…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 2…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Acco…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufact…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged i…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottle…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed b…
FDA Drug · Class II · 2023-03-08 · Alvogen - Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Ph…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-…
FDA Drug · Class II · 2023-03-08 · Nephron Sc - rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcare,…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by…
FDA Drug · Class III · 2023-03-08 · Dupont Nutrition Usa - Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries…
FDA Drug · Class II · 2023-03-08 · The Harvard Drug Group - Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by…
FDA Drug · Class III · 2023-03-08 · Dupont Nutrition Usa - Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by:…
FDA Drug · Class III · 2023-03-08 · Dupont Nutrition Usa - Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactu…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured for: Accord Healthcar…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufact…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactu…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Contain…
FDA Drug · Class III · 2023-03-08 · Sca Pharmaceuticals - Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by:…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50…
FDA Drug · Class III · 2023-03-08 · Sciegen Pharmaceuticals - Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord Healthcar…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPon…
FDA Drug · Class III · 2023-03-08 · Dupont Nutrition Usa - Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los An…
FDA Drug · Class I · 2023-03-08 · Volt Candy Wholesale Club - rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: In…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactur…
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5
FDA Drug · Class II · 2023-03-08 · Accord Healthcare - TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL
FDA Drug · Class II · 2023-03-01 · Ibsa Pharma - Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA
FDA Drug · Class II · 2023-03-01 · Dr Reddy S Laboratories - TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL
FDA Drug · Class II · 2023-03-01 · Ibsa Pharma - TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL
FDA Drug · Class II · 2023-03-01 · Ibsa Pharma - TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL
FDA Drug · Class II · 2023-03-01 · Ibsa Pharma - TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL
FDA Drug · Class II · 2023-03-01 · Ibsa Pharma
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)