FDA Drug · 2019
FDA Drug recalls in 2019
RecallRadar indexes 2,152 FDA Drug recall notices published in 2019. By classification: 511 Class I, 1,497 Class II, 144 Class III.
- Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial
FDA Drug · Class II · 2019-10-09 · Alkermes - C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
FDA Drug · Class II · 2019-10-09 · Colonia Care Pharmacy - NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commer…
FDA Drug · Class II · 2019-10-09 · Krs Global Biotechnology - Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global B…
FDA Drug · Class II · 2019-10-09 · Krs Global Biotechnology - NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of…
FDA Drug · Class II · 2019-10-09 · Krs Global Biotechnology - SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global…
FDA Drug · Class II · 2019-10-09 · Krs Global Biotechnology - Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045
FDA Drug · Class II · 2019-10-09 · Akorn - Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Ba…
FDA Drug · Class II · 2019-10-09 · Torrent Pharma - C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
FDA Drug · Class II · 2019-10-09 · Colonia Care Pharmacy - Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Bl…
FDA Drug · Class II · 2019-10-09 · Krs Global Biotechnology - OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 7…
FDA Drug · Class II · 2019-10-09 · Krs Global Biotechnology - Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2019-10-09 · Krs Global Biotechnology - Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Bas…
FDA Drug · Class II · 2019-10-09 · Torrent Pharma - Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, KRS…
FDA Drug · Class II · 2019-10-09 · Krs Global Biotechnology - LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerc…
FDA Drug · Class II · 2019-10-09 · Krs Global Biotechnology - L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce B…
FDA Drug · Class II · 2019-10-09 · Krs Global Biotechnology - Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For IV/SC/IM Use, Rx Only, KRS Global Biotechnology 7…
FDA Drug · Class II · 2019-10-09 · Krs Global Biotechnology - Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 6878…
FDA Drug · Class II · 2019-10-02 · Preferred Pharmaceuticals - minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's…
FDA Drug · Class III · 2019-10-02 · Epi Health - Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: S…
FDA Drug · Class I · 2019-10-02 · Shire Human Genetic Therapies - ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands
FDA Drug · Class III · 2019-10-02 · Pfizer - Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045
FDA Drug · Class II · 2019-10-02 · Akorn - Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NP…
FDA Drug · Class I · 2019-10-02 · Shire Human Genetic Therapies - Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856)…
FDA Drug · Class II · 2019-10-02 · Johnson Matthey - Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKli…
FDA Drug · Class II · 2019-10-02 · Cardinal Health - Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer…
FDA Drug · Class III · 2019-10-02 · Pfizer - Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 3…
FDA Drug · Class II · 2019-10-02 · Johnson Matthey - Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Sh…
FDA Drug · Class I · 2019-10-02 · Shire Human Genetic Therapies - Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05
FDA Drug · Class I · 2019-10-02 · Darmerica - Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742…
FDA Drug · Class II · 2019-10-02 · Johnson Matthey - Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Sh…
FDA Drug · Class I · 2019-10-02 · Shire Human Genetic Therapies - Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-073-14), b) 2 Oz (NDC 69804-073-15), and c) 4 Oz (ND…
FDA Drug · Class II · 2019-09-25 · Ridge Properties - Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-070-05), b) 2 OZ (NDC 69804-070-02), and c) 4 OZ (NDC 698…
FDA Drug · Class II · 2019-09-25 · Ridge Properties - Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ…
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 727…
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15…
FDA Drug · Class II · 2019-09-25 · Ridge Properties - fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, N…
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1)…
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 13…
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1)
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), an…
FDA Drug · Class II · 2019-09-25 · Ridge Properties - Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0…
FDA Drug · Class II · 2019-09-25 · West Ward Columbus - Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrencevi…
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 1…
FDA Drug · Class II · 2019-09-25 · Torrent Pharma - Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 6001…
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4 OZ (NDC 69804-074-…
FDA Drug · Class II · 2019-09-25 · Ridge Properties - Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14), b) 2 Oz (NDC 69804-077-15), and c) 4 Oz (NDC 69804…
FDA Drug · Class II · 2019-09-25 · Ridge Properties - Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mar…
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53)
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc
FDA Drug · Class III · 2019-09-18 · Macleods Pharma Usa - Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count c…
FDA Drug · Class I · 2019-09-18 · Plastikon Healthcare - Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth S…
FDA Drug · Class II · 2019-09-18 · Pacifico National - 20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle
FDA Drug · Class II · 2019-09-18 · Compounded Solutions In Pharmacy - Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distribut…
FDA Drug · Class III · 2019-09-18 · American Health Packaging - Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505
FDA Drug · Class III · 2019-09-18 · Mylan Pharmaceuticals - Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth…
FDA Drug · Class II · 2019-09-18 · Pacifico National - AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50
FDA Drug · Class II · 2019-09-18 · Avkare - Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01
FDA Drug · Class II · 2019-09-18 · Pfizer - 5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles
FDA Drug · Class II · 2019-09-18 · Compounded Solutions In Pharmacy - 10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
FDA Drug · Class II · 2019-09-18 · Compounded Solutions In Pharmacy - Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial
FDA Drug · Class II · 2019-09-04 · Alkermes - Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc.,…
FDA Drug · Class III · 2019-09-04 · Akorn - Simvastatin Tablets, USP 40 mg
FDA Drug · Class III · 2019-09-04 · Aurobindo Pharma Usa - Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc.,…
FDA Drug · Class III · 2019-09-04 · Akorn - RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45
FDA Drug · Class II · 2019-09-04 · Pfizer - Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Via…
FDA Drug · Class III · 2019-09-04 · Akorn - Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display
FDA Drug · Class II · 2019-08-28 · Medtech Products - Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369
FDA Drug · Class II · 2019-08-28 · Upsher Smith Laboratories - Clear Eyes Redness Relief Hand Pocket Pal Tray Display
FDA Drug · Class II · 2019-08-28 · Medtech Products - Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medt…
FDA Drug · Class II · 2019-08-28 · Medtech Products - Clear Eyes Redness Relief Club Pack Display
FDA Drug · Class II · 2019-08-28 · Medtech Products - Clear Eyes Assorted IRC Display
FDA Drug · Class II · 2019-08-28 · Medtech Products - Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 7811…
FDA Drug · Class II · 2019-08-28 · Medtech Products - Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display
FDA Drug · Class II · 2019-08-28 · Medtech Products - Clear Eyes Assorted Sidekick Floor Stand Display
FDA Drug · Class II · 2019-08-28 · Medtech Products - Clear Eyes Maximum Redness Relief Club Pack Display
FDA Drug · Class II · 2019-08-28 · Medtech Products - Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display
FDA Drug · Class II · 2019-08-28 · Medtech Products - Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. by…
FDA Drug · Class II · 2019-08-28 · Medtech Products - Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display
FDA Drug · Class II · 2019-08-28 · Medtech Products - Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bot…
FDA Drug · Class II · 2019-08-28 · Medtech Products - Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceutica…
FDA Drug · Class II · 2019-08-28 · Sca Pharmaceuticals - Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distribu…
FDA Drug · Class II · 2019-08-28 · Medtech Products - AVASTIN 630 MG / 100 ML 0.9% NACL IVPB
FDA Drug · Class II · 2019-08-21 · Infusion Options - Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc.…
FDA Drug · Class II · 2019-08-21 · Lupin Pharmaceuticals - Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc
FDA Drug · Class II · 2019-08-21 · Us Pharmaceuticals - VELCADE 2.1 mg / 0.84 ml SQ SYRINGE
FDA Drug · Class II · 2019-08-21 · Infusion Options - PERTUZUMAB 840 MG/250 ml0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
FDA Drug · Class II · 2019-08-21 · Infusion Options - PEMETREXED 910 MG QS 100 ML NS IVPB
FDA Drug · Class II · 2019-08-21 · Infusion Options - ERIBULIN 1.12 MG / 100 ML NS IVPB
FDA Drug · Class II · 2019-08-21 · Infusion Options - Gemcitabine 1910 MG / 250 ML NS IVPB
FDA Drug · Class II · 2019-08-21 · Infusion Options - Cytarabine 128 MG/250 ML D5W IVPB
FDA Drug · Class II · 2019-08-21 · Infusion Options - CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629
FDA Drug · Class II · 2019-08-21 · Us Pharmaceuticals - IRON SUCROSE 200 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
FDA Drug · Class II · 2019-08-21 · Infusion Options - Adult Glycerin Suppositories, Package Size 50-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015
FDA Drug · Class II · 2019-08-21 · Us Pharmaceuticals - Cyclophosphamide 840 MG / 250 ML NS IVPB
FDA Drug · Class II · 2019-08-21 · Infusion Options - Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB
FDA Drug · Class II · 2019-08-21 · Infusion Options - DECITABINE 40 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
FDA Drug · Class II · 2019-08-21 · Infusion Options - InFLIXimab 300 mg / 250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
FDA Drug · Class II · 2019-08-21 · Infusion Options - DIPHENHYDRAMINE 25 MG/50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
FDA Drug · Class II · 2019-08-21 · Infusion Options
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)