Category
Oral Drugs Recalls
5,039 oral drugs recalls on record from CPSC, FDA, and USDA.
5,039 recalls
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India....
Oral Drugs0 affectedOct 19, 2023
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India....
Oral Drugs0 affectedOct 19, 2023
CriticalFDA
Vistapharm Llc
Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: Vista...
Oral Drugs180 affectedOct 18, 2023
RecallFDA
Abbvie Inc.
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC ...
Oral Drugs864 affectedOct 17, 2023
RecallFDA
Vistapharm Llc
Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc...
Oral Drugs22 affectedOct 17, 2023
CriticalFDA
Noah's Wholesale Llc
THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL ...
Oral Drugs173 affectedOct 16, 2023
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made i...
Oral Drugs1,656 affectedOct 13, 2023
RecallFDA
Sun Pharmaceutical Industries Inc
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industr...
Oral Drugs144 affectedOct 4, 2023
CriticalFDA
Scynexis, Inc.
BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ ...
Oral Drugs17,376 affectedSep 25, 2023
RecallFDA
West-ward Columbus Inc
Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontow...
Oral Drugs2,673 affectedSep 22, 2023
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, ...
Oral Drugs7,248 affectedSep 21, 2023
CriticalFDA
Kvk-tech, Inc.
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
Oral Drugs1,488 affectedSep 20, 2023
CriticalFDA
Church & Dwight Inc
TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 970...
Oral Drugs5,316 affectedSep 8, 2023
CriticalFDA
Novartis Pharmaceuticals Corp.
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., ...
Oral Drugs1,272 affectedSep 8, 2023
RecallFDA
Amerisource Health Services Llc
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Colu...
Oral Drugs3,344 affectedSep 1, 2023
High RiskFDA
Vistapharm Llc
Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPhar...
Oral Drugs14,400 affectedAug 30, 2023
High RiskFDA
Marlex Pharmaceuticals, Inc.
Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE ND...
Oral Drugs94 affectedAug 25, 2023
CriticalFDA
Marlex Pharmaceuticals, Inc.
Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE N...
Oral Drugs94 affectedAug 25, 2023
CriticalFDA
Hua Da Trading, Inc. Dba Wefun Inc.
WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
Oral Drugs300 affectedAug 25, 2023
RecallFDA
Lundbeck Llc
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Oral Drugs10,543 affectedAug 17, 2023
RecallFDA
Esperion
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 481...
Oral Drugs45,240 affectedAug 16, 2023
RecallFDA
Glenmark Pharmaceuticals Inc., Usa
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pha...
Oral Drugs1,200 affectedAug 14, 2023
CriticalFDA
Apg Seven, Inc
Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stan...
Oral Drugs120 affectedAug 3, 2023
High RiskFDA
Aurobindo Pharma Usa Inc.
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Oral Drugs9,890 affectedAug 2, 2023
High RiskFDA
Aurobindo Pharma Usa Inc.
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightst...
Oral Drugs48 affectedJul 21, 2023
High RiskFDA
Aurobindo Pharma Usa Inc.
Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightst...
Oral Drugs48 affectedJul 21, 2023
RecallFDA
Sun Pharmaceutical Industries Inc
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, ...
Oral Drugs360 affectedJul 18, 2023
RecallFDA
Ascend Laboratories, Llc
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Di...
Oral Drugs99,516 affectedJul 18, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, ...
Oral Drugs7,313 affectedJul 13, 2023
High RiskFDA
Ascend Laboratories, Llc
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratori...
Oral Drugs2,652 affectedJul 11, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufacture...
Oral Drugs8,880 affectedJul 10, 2023
High RiskFDA
Teva Pharmaceuticals Usa Inc
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, ND...
Oral Drugs180 affectedJul 5, 2023
RecallFDA
Lupin Pharmaceuticals Inc.
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21...
Oral Drugs3,096 affectedJun 27, 2023
High RiskFDA
Strides Pharma Inc.
Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limi...
Oral Drugs2,700 affectedJun 26, 2023
High RiskFDA
Preferred Pharmaceuticals, Inc.
Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-co...
Oral Drugs541 affectedJun 26, 2023
CriticalFDA
Lupin Pharmaceuticals Inc.
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg...
Oral Drugs4,179 affectedJun 23, 2023
RecallFDA
Vivus, Inc.
PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UP...
Oral Drugs4,240 affectedJun 23, 2023
High RiskFDA
Amerisource Health Services Llc
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: Am...
Oral Drugs4,971 affectedJun 23, 2023
High RiskFDA
Dr Reddy's Laboratories Limited
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. ND...
Oral Drugs17,548 affectedJun 21, 2023
High RiskFDA
The Harvard Drug Group
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Surve...
Oral Drugs3,876 affectedJun 16, 2023
RecallFDA
Avkare Llc
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Oral Drugs592 affectedJun 13, 2023
RecallFDA
Amring Pharmaceuticals Inc
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 1...
Oral Drugs48,989 affectedJun 12, 2023
High RiskFDA
Homeocare Laboratories, Inc.
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16
Oral Drugs16,587 affectedJun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01
Oral Drugs33,109 affectedJun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02
Oral Drugs40,034 affectedJun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16
Oral Drugs130,762 affectedJun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02
Oral Drugs38,105 affectedJun 5, 2023
CriticalFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500...
Oral Drugs0 affectedMay 31, 2023