FDA Drug · 2018
FDA Drug recalls in 2018
RecallRadar indexes 1,426 FDA Drug recall notices published in 2018. By classification: 107 Class I, 1,166 Class II, 153 Class III.
- Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with glass dropper, MBi Nu…
FDA Drug · Class II · 2018-06-20 · Mbi Distributing - RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDL…
FDA Drug · Class II · 2018-06-20 · Rij Pharmaceutical - Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber PET bottle with white sprayer
FDA Drug · Class II · 2018-06-20 · Mbi Distributing - Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
FDA Drug · Class II · 2018-06-20 · Inopak - Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 165…
FDA Drug · Class II · 2018-06-20 · Rij Pharmaceutical - Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) tube, Distributed by: United Exchange Corp., 17211 Valley View…
FDA Drug · Class II · 2018-06-20 · Shadow Holdings - Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvi…
FDA Drug · Class I · 2018-06-20 · Allergan - Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and…
FDA Drug · Class I · 2018-06-13 · Hospira Lake Forest - Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Ma…
FDA Drug · Class II · 2018-06-13 · Apotex - Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, I…
FDA Drug · Class III · 2018-06-13 · Pharmaceutical Associates - Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd
FDA Drug · Class III · 2018-06-13 · Jubilant Cadista Pharmaceuticals - 7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
FDA Drug · Class I · 2018-06-06 · Shoreside Enterprises - Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc
FDA Drug · Class III · 2018-06-06 · Lupin Somerset - POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, U…
FDA Drug · Class I · 2018-06-06 · Shoreside Enterprises - My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured…
FDA Drug · Class II · 2018-05-30 · Lupin Pharmaceuticals - screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4
FDA Drug · Class II · 2018-05-30 · Ideaz - Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
FDA Drug · Class II · 2018-05-30 · Mylan Pharmaceuticals - screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5
FDA Drug · Class II · 2018-05-30 · Ideaz - PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
FDA Drug · Class II · 2018-05-30 · Mylan Pharmaceuticals - T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Ha…
FDA Drug · Class III · 2018-05-30 · Milbar Laboratories - 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10
FDA Drug · Class II · 2018-05-30 · Fresenius Medical Care Renal Therapies Group - PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
FDA Drug · Class II · 2018-05-30 · Mylan Pharmaceuticals - Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India
FDA Drug · Class II · 2018-05-30 · Exela Pharma Sciences - Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)
FDA Drug · Class III · 2018-05-30 · Teva Pharmaceuticals Usa - My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharma…
FDA Drug · Class II · 2018-05-30 · Lupin Pharmaceuticals - Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc
FDA Drug · Class II · 2018-05-30 · Mylan Institutional D B A Udl Laboratories - Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
FDA Drug · Class III · 2018-05-30 · Milbar Laboratories - Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc
FDA Drug · Class II · 2018-05-30 · Mylan Institutional D B A Udl Laboratories - PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
FDA Drug · Class II · 2018-05-30 · Mylan Pharmaceuticals - Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc
FDA Drug · Class I · 2018-05-30 · Ama Wholesale - Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
FDA Drug · Class II · 2018-05-30 · Mylan Pharmaceuticals - Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
FDA Drug · Class III · 2018-05-23 · Boiron - Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA…
FDA Drug · Class III · 2018-05-23 · Sun Pharmaceutical Industries - Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY,…
FDA Drug · Class II · 2018-05-23 · Milbar Laboratories - Ferrous Sulfate 325 MG tablet
FDA Drug · Class III · 2018-05-23 · Aidarex Pharmaceuticals - Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only
FDA Drug · Class II · 2018-05-23 · Prescript Pharmaceuticals - Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only
FDA Drug · Class II · 2018-05-23 · Prescript Pharmaceuticals - Clindamycin 150 mg capsules, USP, 30-count M-Pak container
FDA Drug · Class II · 2018-05-23 · Prescript Pharmaceuticals - Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manu…
FDA Drug · Class II · 2018-05-23 · Pharmalucence - MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN
FDA Drug · Class II · 2018-05-23 · Milbar Laboratories - Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only
FDA Drug · Class II · 2018-05-23 · Prescript Pharmaceuticals - Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only
FDA Drug · Class II · 2018-05-23 · Prescript Pharmaceuticals - Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
FDA Drug · Class II · 2018-05-23 · Mylan Pharmaceuticals - Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare In…
FDA Drug · Class I · 2018-05-23 · Apotex - Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
FDA Drug · Class II · 2018-05-23 · Mylan Pharmaceuticals - Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St…
FDA Drug · Class II · 2018-05-23 · Sun Pharmaceutical Industries - B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
FDA Drug · Class II · 2018-05-23 · Milbar Laboratories - Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84)
FDA Drug · Class II · 2018-05-23 · L Perrigo - Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for:…
FDA Drug · Class I · 2018-05-23 · Auromedics Pharma - Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare…
FDA Drug · Class I · 2018-05-23 · Apotex - Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010…
FDA Drug · Class II · 2018-05-23 · Perrigo New York - Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354
FDA Drug · Class II · 2018-05-23 · Milbar Laboratories - Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
FDA Drug · Class II · 2018-05-16 · Vitalab Pharmacy - Promacta 50 mg tablet NDC 00078-0686-15 30 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Botox 100 Units Vial NDC 00023-1145-01 90 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Ibrance 125 mg cap NDC 00069-0189-21 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Altera Handset NDC 83490-0678-05 56 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02)
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Xolair 150 mg SDV NDC 50242-0040-62 28 days
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Ace…
FDA Drug · Class II · 2018-05-16 · Coast Quality Pharmacy - Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc
FDA Drug · Class II · 2018-05-16 · Vitalab Pharmacy - Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited…
FDA Drug · Class II · 2018-05-16 · Dr Reddy S Laboratories - Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
FDA Drug · Class II · 2018-05-16 · Vitalab Pharmacy - Cayston 75 mg Inh
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8…
FDA Drug · Class II · 2018-05-16 · Noven Pharmaceuticals - Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Xalkori 250 mg cap NDC 00069-8140-20 30 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL,…
FDA Drug · Class II · 2018-05-16 · Vitalab Pharmacy - Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pha…
FDA Drug · Class I · 2018-05-16 · Auromedics Pharma - Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by S…
FDA Drug · Class III · 2018-05-16 · Septodont - Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - MVW Complete Softgels NDC 58204-0004-00 30 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy - Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply
FDA Drug · Class II · 2018-05-16 · Kroger Specialty Pharmacy
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)