FDA Drug · 2020
FDA Drug recalls in 2020
RecallRadar indexes 1,035 FDA Drug recall notices published in 2020. By classification: 109 Class I, 824 Class II, 102 Class III.
- CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc
FDA Drug · Class III · 2020-03-04 · Akorn - TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactu…
FDA Drug · Class III · 2020-03-04 · Golden State Medical Supply - Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015
FDA Drug · Class III · 2020-03-04 · Akorn - Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Cart…
FDA Drug · Class III · 2020-03-04 · Breckenridge Pharmaceutical - Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05)…
FDA Drug · Class III · 2020-02-26 · Teva Pharmaceuticals Usa - Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Pa…
FDA Drug · Class II · 2020-02-26 · American Health Packaging - Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Pa…
FDA Drug · Class II · 2020-02-26 · American Health Packaging - Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmac…
FDA Drug · Class III · 2020-02-26 · The Harvard Drug Group - Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141
FDA Drug · Class II · 2020-02-26 · Ncs Healthcare - Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for…
FDA Drug · Class III · 2020-02-26 · Auromedics Pharma - Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of…
FDA Drug · Class II · 2020-02-19 · Pfizer - Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton
FDA Drug · Class II · 2020-02-19 · Gsk Consumer Health - Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services…
FDA Drug · Class III · 2020-02-19 · Par Pharmaceutical - Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin OH…
FDA Drug · Class II · 2020-02-19 · Contract Pharmacal - Kushim Tablets (Gushim) 45-count packages, Label in foreign language
FDA Drug · Class II · 2020-02-19 · B And A Trading - New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc
FDA Drug · Class II · 2020-02-19 · Efficient Laboratories - Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00
FDA Drug · Class I · 2020-02-19 · Remedyrepack - Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of…
FDA Drug · Class II · 2020-02-19 · Pfizer - Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc
FDA Drug · Class II · 2020-02-19 · Efficient Laboratories - Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princet…
FDA Drug · Class II · 2020-02-19 · Auromedics Pharma - Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701
FDA Drug · Class II · 2020-02-19 · Akorn - Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wa…
FDA Drug · Class II · 2020-02-19 · Teva Pharmaceuticals Usa - Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Pack…
FDA Drug · Class II · 2020-02-19 · American Health Packaging - Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60
FDA Drug · Class II · 2020-02-19 · Contract Pharmacal - Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc
FDA Drug · Class II · 2020-02-19 · Lupin Pharmaceuticals - Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscu…
FDA Drug · Class II · 2020-02-19 · Pfizer - Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc
FDA Drug · Class II · 2020-02-19 · Efficient Laboratories - Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India,…
FDA Drug · Class II · 2020-02-19 · Zydus Pharmaceuticals Usa - Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wa…
FDA Drug · Class II · 2020-02-19 · Teva Pharmaceuticals Usa - Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd
FDA Drug · Class I · 2020-02-19 · Taro Pharmaceuticals U - Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams…
FDA Drug · Class II · 2020-02-12 · Spectrum Laboratory Products - Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc
FDA Drug · Class II · 2020-02-12 · Teva Pharmaceuticals Usa - Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd
FDA Drug · Class III · 2020-02-12 · Unichem Pharmaceuticals Usa - Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc
FDA Drug · Class III · 2020-02-12 · Macleods Pharma Usa - Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc
FDA Drug · Class II · 2020-02-12 · Teva Pharmaceuticals Usa - Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA
FDA Drug · Class II · 2020-02-12 · Graviti Pharmaceuticals Private - ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14)
FDA Drug · Class II · 2020-02-12 · Pd Rx Pharmaceuticals - Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distr…
FDA Drug · Class II · 2020-02-12 · Ascend Laboratories - Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumba…
FDA Drug · Class III · 2020-02-12 · Ascend Laboratories - Liothyronine (T3) 92.5 MCG
FDA Drug · Class II · 2020-02-05 · Mprx - Tadalafil 6 mg Capsule
FDA Drug · Class II · 2020-02-05 · Mprx - Naltrexone 4.5 mg capsule
FDA Drug · Class II · 2020-02-05 · Mprx - Squaric Acid 0.1% Topical Solution (Clinic) 30 mL
FDA Drug · Class II · 2020-02-05 · Mprx - Testosterone Topical Cream 4%
FDA Drug · Class II · 2020-02-05 · Mprx - Progesterone 50 mg capsules
FDA Drug · Class II · 2020-02-05 · Mprx - DHEA/Pregnenol One 10.25 MG Cap
FDA Drug · Class II · 2020-02-05 · Mprx - Tadalafil 20 mg Troche
FDA Drug · Class II · 2020-02-05 · Mprx - T3/T4 SR 9 mcg/38 mcg capsule
FDA Drug · Class II · 2020-02-05 · Mprx - Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, D…
FDA Drug · Class II · 2020-02-05 · Shandex Personal Care Manufacturing - Sildenafil 80 mg capsules
FDA Drug · Class II · 2020-02-05 · Mprx - Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars
FDA Drug · Class II · 2020-02-05 · Mprx - Progesterone E4M SR 100 mg capsules
FDA Drug · Class II · 2020-02-05 · Mprx - Sildenafil 200 mg Troche (Clinic)
FDA Drug · Class II · 2020-02-05 · Mprx - Liothyronine (T3) 80 mcg SR cap
FDA Drug · Class II · 2020-02-05 · Mprx - Finasteride/Biotin 1 mg/50 mcg
FDA Drug · Class II · 2020-02-05 · Mprx - Magic Bullet Supplement
FDA Drug · Class II · 2020-02-05 · Mprx - Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars
FDA Drug · Class II · 2020-02-05 · Mprx - Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc
FDA Drug · Class II · 2020-02-05 · Mcguff Compounding Pharmacy Services - Progesterone 200 mg Troche
FDA Drug · Class II · 2020-02-05 · Mprx - Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc
FDA Drug · Class III · 2020-02-05 · Macleods Pharma Usa - Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc
FDA Drug · Class II · 2020-02-05 · Pharmaceutical Associates - Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70…
FDA Drug · Class II · 2020-01-29 · Denton Pharma - Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
FDA Drug · Class II · 2020-01-29 · Remedyrepack - Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93
FDA Drug · Class II · 2020-01-29 · Mylan Pharmaceuticals - Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count
FDA Drug · Class II · 2020-01-29 · H J Harkins - methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA
FDA Drug · Class III · 2020-01-29 · Hikma Pharmaceuticals Usa - Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6…
FDA Drug · Class II · 2020-01-29 · Preferred Pharmaceuticals - Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 687…
FDA Drug · Class II · 2020-01-29 · Preferred Pharmaceuticals - Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: No…
FDA Drug · Class II · 2020-01-29 · Denton Pharma - NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanc…
FDA Drug · Class II · 2020-01-29 · Advanced Accelerator Applications Usa - Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91
FDA Drug · Class II · 2020-01-29 · Mylan Pharmaceuticals - Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
FDA Drug · Class II · 2020-01-29 · Tuscano And Delucia Group Dba Entropic Labs - Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-2…
FDA Drug · Class I · 2020-01-22 · Hikma Pharmaceuticals Usa - MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by…
FDA Drug · Class II · 2020-01-22 · Sun Pharmaceutical Industries - HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 coun…
FDA Drug · Class I · 2020-01-22 · Motto International - BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - CLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - HYDROMORPHONE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - Alprostadil 40 mcg/mL (2 mL vial) Inj
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - BUP 7MG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - HYDROM 10MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - MORP 20MG/SUF 70MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - MORPHINE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion - BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Drug · Class II · 2020-01-22 · Assurance Infusion
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)