FDA Drug · 2021
FDA Drug recalls in 2021
RecallRadar indexes 1,016 FDA Drug recall notices published in 2021. By classification: 135 Class I, 779 Class II, 102 Class III.
- Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manu…
FDA Drug · Class III · 2021-05-26 · Nomax - PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
FDA Drug · Class II · 2021-05-26 · Hyobin - Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd
FDA Drug · Class III · 2021-05-26 · Kvk Tech - Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10
FDA Drug · Class III · 2021-05-26 · Sigmapharm Laboratories - Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673
FDA Drug · Class II · 2021-05-26 · Bit And Bet - Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc
FDA Drug · Class II · 2021-05-26 · Lupin Pharmaceuticals - Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries,…
FDA Drug · Class II · 2021-05-19 · Sun Pharmaceutical Industries - BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution,…
FDA Drug · Class I · 2021-05-19 · Carefusion 213 - heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL) b…
FDA Drug · Class I · 2021-05-12 · Pnhc - PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
FDA Drug · Class II · 2021-05-12 · Qmart - Burro en Primavera, 2 capsules, UPC 638632431055
FDA Drug · Class II · 2021-05-12 · Qmart - Imperial Platinum 2000, 1 capsule, UPC 718122040702
FDA Drug · Class II · 2021-05-12 · Qmart - Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152
FDA Drug · Class I · 2021-05-12 · A S Medication Solutions - IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702
FDA Drug · Class II · 2021-05-12 · Qmart - Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3
FDA Drug · Class II · 2021-05-12 · Antoto K - Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01
FDA Drug · Class III · 2021-05-12 · Heritage Pharmaceuticals - ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 f…
FDA Drug · Class I · 2021-05-05 · Carefusion 213 - PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542…
FDA Drug · Class II · 2021-05-05 · Namoo Enterprise - Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE Distributors Los A…
FDA Drug · Class II · 2021-05-05 · Na Na Collection - Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc
FDA Drug · Class III · 2021-05-05 · Teligent Pharma - BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 2…
FDA Drug · Class II · 2021-05-05 · Carefusion 213 - BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 2…
FDA Drug · Class I · 2021-05-05 · Carefusion 213 - PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles…
FDA Drug · Class II · 2021-05-05 · Na Na Collection - Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60
FDA Drug · Class II · 2021-05-05 · Pd Rx Pharmaceuticals - ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml…
FDA Drug · Class II · 2021-05-05 · Carefusion 213 - Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, I…
FDA Drug · Class III · 2021-05-05 · Genentech - ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 f…
FDA Drug · Class II · 2021-05-05 · Carefusion 213 - Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5
FDA Drug · Class II · 2021-05-05 · S And B Story - Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc
FDA Drug · Class III · 2021-05-05 · Teligent Pharma - Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc
FDA Drug · Class III · 2021-05-05 · Teligent Pharma - ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml…
FDA Drug · Class I · 2021-05-05 · Carefusion 213 - Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Prefe…
FDA Drug · Class II · 2021-05-05 · Preferred Pharmaceuticals - BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml…
FDA Drug · Class II · 2021-05-05 · Carefusion 213 - BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml…
FDA Drug · Class I · 2021-05-05 · Carefusion 213 - Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder
FDA Drug · Class II · 2021-05-05 · Grace Healthcare Medical - Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC…
FDA Drug · Class II · 2021-04-28 · Edge Pharma - Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc
FDA Drug · Class II · 2021-04-28 · Teligent Pharma - Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc
FDA Drug · Class II · 2021-04-28 · Noven Pharmaceuticals - Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc
FDA Drug · Class II · 2021-04-28 · Noven Pharmaceuticals - Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industria…
FDA Drug · Class II · 2021-04-21 · Spartan Chemical - Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 18 oz/ 532 ml per foam pump container, For I…
FDA Drug · Class II · 2021-04-21 · Spartan Chemical - Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Man…
FDA Drug · Class III · 2021-04-21 · Macleods Pharma Usa - Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Ma…
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India
FDA Drug · Class II · 2021-04-21 · Jubilant Cadista Pharmaceuticals - Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S…
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC,…
FDA Drug · Class II · 2021-04-21 · Sun Pharmaceutical Industries - OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample
FDA Drug · Class II · 2021-04-21 · Novo Nordisk - Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only, Manufactured by: Novo Nordisk A/S…
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutio…
FDA Drug · Class I · 2021-04-21 · Spartan Chemical - Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01)
FDA Drug · Class II · 2021-04-21 · Lupin Pharmaceuticals - Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional an…
FDA Drug · Class II · 2021-04-21 · Spartan Chemical - ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordi…
FDA Drug · Class II · 2021-04-21 · Novo Nordisk - Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceutica…
FDA Drug · Class III · 2021-04-21 · Asclemed Usa - Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Instit…
FDA Drug · Class II · 2021-04-21 · Spartan Chemical - foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27 oz/1250 ml per foam pump cartridge, For Institutiona…
FDA Drug · Class II · 2021-04-21 · Spartan Chemical - Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample
FDA Drug · Class II · 2021-04-21 · Novo Nordisk - Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufacture…
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S…
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14
FDA Drug · Class III · 2021-04-21 · Teligent Pharma - LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260 J R Hawvermale Way…
FDA Drug · Class III · 2021-04-14 · Washington Homeopathic Products - Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ…
FDA Drug · Class II · 2021-04-14 · Sun Pharmaceutical Industries - Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed…
FDA Drug · Class II · 2021-04-14 · Cosette Pharmaceuticals - Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav…
FDA Drug · Class I · 2021-04-14 · Alembic Pharmaceuticals - Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc…
FDA Drug · Class III · 2021-04-14 · Sun Pharmaceutical Industries - Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA…
FDA Drug · Class II · 2021-04-14 · Kimberly Clark - Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411
FDA Drug · Class III · 2021-04-14 · Washington Homeopathic Products - Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc
FDA Drug · Class II · 2021-04-14 · X Gen Pharmaceuticals - Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc
FDA Drug · Class II · 2021-04-14 · Apotex - Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc
FDA Drug · Class III · 2021-04-14 · Washington Homeopathic Products - Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged…
FDA Drug · Class I · 2021-04-07 · Zydus Pharmaceuticals Usa - ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonst…
FDA Drug · Class II · 2021-04-07 · Ferring Pharmaceuticals - Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., H…
FDA Drug · Class III · 2021-04-07 · Cardinal Health - Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, package…
FDA Drug · Class I · 2021-04-07 · Zydus Pharmaceuticals Usa - ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 De…
FDA Drug · Class II · 2021-04-07 · Ferring Pharmaceuticals - Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5
FDA Drug · Class I · 2021-03-31 · Adams Secret - Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA,…
FDA Drug · Class II · 2021-03-31 · Golden State Medical Supply - Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6
FDA Drug · Class I · 2021-03-31 · Adams Secret - 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 U…
FDA Drug · Class II · 2021-03-31 · Icu Medical - Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercule…
FDA Drug · Class III · 2021-03-24 · Edge Pharma - Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc
FDA Drug · Class III · 2021-03-24 · Teva Pharmaceuticals Usa - Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124…
FDA Drug · Class II · 2021-03-24 · Bryant Ranch Prepack - Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech P…
FDA Drug · Class II · 2021-03-24 · Akorn - Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge P…
FDA Drug · Class III · 2021-03-24 · Edge Pharma - Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intraveno…
FDA Drug · Class II · 2021-03-24 · Sagent Pharmaceuticals - Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 61919…
FDA Drug · Class II · 2021-03-24 · Direct Rx - Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-co…
FDA Drug · Class I · 2021-03-24 · Bryant Ranch Prepack - Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT,…
FDA Drug · Class II · 2021-03-24 · Breckenridge Pharmaceutical - Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% So…
FDA Drug · Class III · 2021-03-17 · Ferring Pharmaceuticals - Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Pars…
FDA Drug · Class II · 2021-03-10 · Teva Pharmaceuticals Usa - Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured…
FDA Drug · Class III · 2021-03-10 · Sun Pharmaceutical Industries - Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene t…
FDA Drug · Class II · 2021-03-10 · Noven Pharmaceuticals - Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropyl…
FDA Drug · Class II · 2021-03-10 · Noven Pharmaceuticals - Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Wi…
FDA Drug · Class II · 2021-03-10 · Aurobindo Pharma Usa - Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene…
FDA Drug · Class II · 2021-03-10 · Noven Pharmaceuticals - Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE
FDA Drug · Class II · 2021-03-10 · Dr Reddy S Laboratories
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)