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.
- Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe
FDA Drug · Class II · 2018-07-25 · Avella Of Deer Valley Store 38 - 0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump
FDA Drug · Class II · 2018-07-25 · Avella Of Deer Valley Store 38 - HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag
FDA Drug · Class II · 2018-07-25 · Avella Of Deer Valley Store 38 - EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag
FDA Drug · Class II · 2018-07-25 · Avella Of Deer Valley Store 38 - NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe
FDA Drug · Class II · 2018-07-25 · Avella Of Deer Valley Store 38 - PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag
FDA Drug · Class II · 2018-07-25 · Avella Of Deer Valley Store 38 - Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag
FDA Drug · Class II · 2018-07-25 · Avella Of Deer Valley Store 38 - 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette
FDA Drug · Class II · 2018-07-25 · Avella Of Deer Valley Store 38 - NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Sin…
FDA Drug · Class II · 2018-07-25 · Avella Of Deer Valley Store 38 - ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe
FDA Drug · Class II · 2018-07-25 · Avella Of Deer Valley Store 38 - NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single dose bag
FDA Drug · Class II · 2018-07-25 · Avella Of Deer Valley Store 38 - MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe
FDA Drug · Class II · 2018-07-25 · Avella Of Deer Valley Store 38 - Gaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American…
FDA Drug · Class III · 2018-07-18 · American Health Packaging - Gaia Kratom (mitragyna speciosa) powder, Yellow Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, Red Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, Green MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, Green Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, White Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physi…
FDA Drug · Class II · 2018-07-18 · Sanofi Aventis U S - Gaia Kratom (mitragyna speciosa) powder, Green Kapuas Hulu, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Enalapril Maleate Tablets USP
FDA Drug · Class III · 2018-07-18 · Wockhardt - Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West P…
FDA Drug · Class II · 2018-07-18 · Medi Fare Drug And Home Health Center - Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , S…
FDA Drug · Class II · 2018-07-18 · Sca Pharmaceuticals - Gaia Kratom (mitragyna speciosa) powder, Ganesh, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: Med…
FDA Drug · Class II · 2018-07-18 · Medgyn Products - Gaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only
FDA Drug · Class II · 2018-07-18 · Akorn - Gaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Enalapril Maleate Tablets USP
FDA Drug · Class III · 2018-07-18 · Wockhardt - Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc
FDA Drug · Class III · 2018-07-18 · Mylan Pharmaceuticals - Gaia Kratom (mitragyna speciosa) powder, Green Malay, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc
FDA Drug · Class II · 2018-07-18 · Lupin Somerset - Gaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City,…
FDA Drug · Class II · 2018-07-18 · Teva Pharmaceuticals Usa - Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only
FDA Drug · Class I · 2018-07-18 · Auromedics Pharma - Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical Red Borneo, 1oz, 25…
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, White Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Gaia Kratom (mitragyna speciosa) powder, Green Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
FDA Drug · Class I · 2018-07-18 · Gaia Ethnobotanical - Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
FDA Drug · Class II · 2018-07-11 · Sca Pharmaceuticals - Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b)…
FDA Drug · Class III · 2018-07-11 · Lupin Somerset - Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
FDA Drug · Class II · 2018-07-11 · Sca Pharmaceuticals - Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
FDA Drug · Class II · 2018-07-11 · Sca Pharmaceuticals - eb5 Skincare that Works
FDA Drug · Class II · 2018-07-11 · Eb5 - ESTRADIOL 20mg PELLET, 1-count 3ml amber vial
FDA Drug · Class III · 2018-07-11 · Qualgen - Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
FDA Drug · Class II · 2018-07-11 · Sca Pharmaceuticals - Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
FDA Drug · Class II · 2018-07-11 · Sca Pharmaceuticals - TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial
FDA Drug · Class III · 2018-07-11 · Qualgen - Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
FDA Drug · Class II · 2018-07-11 · Sca Pharmaceuticals - Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
FDA Drug · Class II · 2018-07-11 · Sca Pharmaceuticals - Morphine Sulfate 1 mg/mL (preservative free
FDA Drug · Class II · 2018-07-11 · Sca Pharmaceuticals - Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceutic…
FDA Drug · Class II · 2018-07-11 · Ingenus Pharmaceuticals - Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
FDA Drug · Class II · 2018-07-11 · Sca Pharmaceuticals - Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
FDA Drug · Class II · 2018-07-11 · Sca Pharmaceuticals - Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron S…
FDA Drug · Class I · 2018-07-11 · Fagron Compounding Services - Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
FDA Drug · Class II · 2018-07-11 · Sca Pharmaceuticals - Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuti…
FDA Drug · Class II · 2018-07-11 · Ingenus Pharmaceuticals - Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
FDA Drug · Class II · 2018-07-11 · Sca Pharmaceuticals - Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron S…
FDA Drug · Class I · 2018-07-11 · Fagron Compounding Services - fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 5…
FDA Drug · Class II · 2018-07-04 · Advanced Pharma - Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd
FDA Drug · Class II · 2018-06-27 · Dr Reddy S Laboratories - 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc
FDA Drug · Class II · 2018-06-27 · Icu Medical - Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd
FDA Drug · Class III · 2018-06-27 · Dr Reddy S Laboratories - Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only,…
FDA Drug · Class III · 2018-06-27 · Dr Reddy S Laboratories - 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc
FDA Drug · Class II · 2018-06-27 · Icu Medical - 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc
FDA Drug · Class II · 2018-06-27 · Icu Medical - Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd
FDA Drug · Class III · 2018-06-27 · Dr Reddy S Laboratories - 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc
FDA Drug · Class II · 2018-06-27 · Icu Medical - 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc
FDA Drug · Class II · 2018-06-27 · Icu Medical - Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley Vie…
FDA Drug · Class II · 2018-06-20 · Shadow Holdings - RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL AVE…
FDA Drug · Class II · 2018-06-20 · Rij Pharmaceutical - Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: Med…
FDA Drug · Class II · 2018-06-20 · Biodiagnostic International - Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bott…
FDA Drug · Class II · 2018-06-20 · Rij Pharmaceutical - Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ PHA…
FDA Drug · Class II · 2018-06-20 · Rij Pharmaceutical - Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne Shave Post-Shave Moi…
FDA Drug · Class II · 2018-06-20 · Shadow Holdings - READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloths, 24-count flexible pack
FDA Drug · Class II · 2018-06-20 · Medline Industries Northpoint Services - RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown,…
FDA Drug · Class II · 2018-06-20 · Rij Pharmaceutical - X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 0050…
FDA Drug · Class II · 2018-06-20 · Shadow Holdings - Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PET bottle with white sprayer
FDA Drug · Class II · 2018-06-20 · Mbi Distributing - Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morga…
FDA Drug · Class III · 2018-06-20 · Mylan Pharmaceuticals - SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwich…
FDA Drug · Class II · 2018-06-20 · Rij Pharmaceutical - Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz., liquid 8 ounce amber PET bottle with Black CRC Cap,…
FDA Drug · Class II · 2018-06-20 · Mbi Distributing - Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Bronchitis. 8 Fl Ounces amber PET bottle with black cap
FDA Drug · Class II · 2018-06-20 · Mbi Distributing - Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent Colic, 1 ounce amber glass bottle with glass dropper, liquid, M…
FDA Drug · Class II · 2018-06-20 · Mbi Distributing - GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204,…
FDA Drug · Class II · 2018-06-20 · Rij Pharmaceutical - Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morning Sickness, and General Nausea, 1 Fl. Ounce amber glass bott…
FDA Drug · Class II · 2018-06-20 · Mbi Distributing - Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vern…
FDA Drug · Class II · 2018-06-20 · Rij Pharmaceutical - Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1…
FDA Drug · Class II · 2018-06-20 · Rij Pharmaceutical - HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
FDA Drug · Class II · 2018-06-20 · Pharmedium Services - Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist
FDA Drug · Class II · 2018-06-20 · Rij Pharmaceutical - Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL.…
FDA Drug · Class II · 2018-06-20 · Rij Pharmaceutical
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)