Drugs Recalls

17,415 recalls in this category

FDA Drug Class II Ongoing

Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries,

February 5, 2024 Sun Pharmaceutical Industries Inc. 54,960 bottles units
FDA Drug Class I Terminated

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.

February 5, 2024 Super Chill Products 3,573 bottles units
FDA Drug Class II Completed

Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small c

February 2, 2024 Bausch Health Companies, Inc. 3,600 cartons units
FDA Drug Class I Ongoing

To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026

February 1, 2024 Integrity Products 2500 boxes units
FDA Drug Class III Ongoing

HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit

February 1, 2024 Amerisource Health Services LLC 2,850 cartons units
FDA Drug Class I Ongoing

RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026

February 1, 2024 Integrity Products 2500 boxes units
FDA Drug Class I Completed

TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 U

February 1, 2024 Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company 59,644 cans units
FDA Drug Class II Terminated

Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816.

February 1, 2024 NATCO Pharma Limited 4260 bottles units
FDA Drug Class II Ongoing

Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304

January 30, 2024 Brassica Pharma Pvt Ltd 355,633 units units
FDA Drug Class II Ongoing

Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356

January 30, 2024 Brassica Pharma Pvt Ltd 355,120 units units
FDA Drug Class II Ongoing

CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895

January 30, 2024 Brassica Pharma Pvt Ltd 159,334 units units
FDA Drug Class II Ongoing

Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298

January 30, 2024 Brassica Pharma Pvt Ltd 315,842 units units
FDA Drug Class III Ongoing

Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTIC

January 25, 2024 Teva Pharmaceuticals USA, Inc. 19,824 cartons units
FDA Drug Class II Terminated

Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.

January 25, 2024 Alpha Aromatics 676 gallons units
FDA Drug Class III Ongoing

Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., Nor

January 25, 2024 Teva Pharmaceuticals USA, Inc. 12,916 cartons units
FDA Drug Class II Terminated

Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11

January 25, 2024 Amerisource Health Services LLC 1,932 cartons units
FDA Drug Class II Ongoing

Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland.

January 23, 2024 Baxter Healthcare Corporation 13,000 bags units
FDA Drug Class II Ongoing

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Off

January 22, 2024 IntegraDose Compounding Services LLC 1,299 syringes units
FDA Drug Class II Terminated

Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

January 19, 2024 Bestco LLC 46 cases/6 pack each units
FDA Drug Class II Terminated

Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS

January 19, 2024 OMEZA LLC 4390 vials units
FDA Drug Class II Terminated

Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials

January 19, 2024 OMEZA LLC 1210 vials units
FDA Drug Class II Terminated

Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 2

January 19, 2024 Bestco LLC a) 1597 cases/ 12 pack each b) 73 cases/4 pack each units
FDA Drug Class II Terminated

Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

January 19, 2024 Bestco LLC 21 cases/4 pack each units
FDA Drug Class II Terminated

CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

January 19, 2024 Bestco LLC 78 cases/18 packs each units
FDA Drug Class II Terminated

Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

January 19, 2024 Bestco LLC 16 cases/4 pack each units
FDA Drug Class II Completed

Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in Indi

January 18, 2024 Sun Pharmaceutical Industries Inc. 54,504 bottles units
FDA Drug Class II Completed

Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical I

January 18, 2024 Sun Pharmaceutical Industries Inc. 1220 bottles units
FDA Drug Class II Completed

Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15

January 18, 2024 Sun Pharmaceutical Industries Inc. 55,272 bottles units
FDA Drug Class III Ongoing

Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01

January 18, 2024 Dr. Reddy's Laboratories, Inc. 59,336 bottles units
FDA Drug Class II Completed

Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/1

January 18, 2024 Sun Pharmaceutical Industries Inc. 19,992 bottles units
FDA Drug Class II Completed

Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Lim

January 18, 2024 Sun Pharmaceutical Industries Inc. 6552 bottles units
FDA Drug Class II Completed

Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limi

January 18, 2024 Sun Pharmaceutical Industries Inc. 15,768 bottles units
FDA Drug Class II Completed

Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Su

January 18, 2024 Sun Pharmaceutical Industries Inc. 11,400 bottles units
FDA Drug Class II Completed

Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical In

January 18, 2024 Sun Pharmaceutical Industries Inc. 14,568 bottles units
FDA Drug Class III Ongoing

Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05

January 18, 2024 Dr. Reddy's Laboratories, Inc. 14,425 bottles units
FDA Drug Class II Completed

Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pha

January 18, 2024 Sun Pharmaceutical Industries Inc. 10,690 bottles units
FDA Drug Class II Completed

Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/

January 18, 2024 Sun Pharmaceutical Industries Inc. 1,728 bottles units
FDA Drug Class II Completed

Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., S

January 18, 2024 Sun Pharmaceutical Industries Inc. 9,408 bottles units
FDA Drug Class II Completed

Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01

January 17, 2024 Henry Schein Inc. and Glove Club HSI Gloves Inc. 1,099 Single Dose Vials units
FDA Drug Class II Ongoing

Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laborato

January 16, 2024 Ascend Laboratories LLC 71,244 sachets units
FDA Drug Class II Ongoing

OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000

January 16, 2024 Den-Mat Holdings, LLC 344 tubes units
FDA Drug Class II Ongoing

Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC

January 16, 2024 Den-Mat Holdings, LLC 10,103 units units
FDA Drug Class II Terminated

Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal

January 15, 2024 Amneal Pharmaceuticals of New York, LLC. 858 bottles units
FDA Drug Class II Ongoing

Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1

January 12, 2024 IntegraDose Compounding Services LLC 281 syringes units
FDA Drug Class I Ongoing

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

January 12, 2024 Neptune Resources, LLC 1,000,000 bottles units
FDA Drug Class I Ongoing

Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

January 12, 2024 Neptune Resources, LLC 117,000 bottles units
FDA Drug Class I Ongoing

Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801

January 12, 2024 Neptune Resources, LLC 4,932 boxes units
FDA Drug Class II Terminated

Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30

January 12, 2024 Golden State Medical Supply Inc. 108 bottles units
FDA Drug Class II Ongoing

Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Pa

January 11, 2024 PAR Sterile Products LLC 1721 cartons units
FDA Drug Class II Terminated

Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-

January 11, 2024 Amerisource Health Services LLC 1,568 cartons units

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