Drug Recalls

2,059 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 1,451–1,500 of 2,059

Drug Recall · November 14, 2024
Keystone Industries
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
Drug Recall · November 14, 2024
MXBBB
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
Class II
Drug Recall · November 14, 2024
Amerisource Health Services LLC
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class II
Drug Recall · November 13, 2024
Brands International Corporation
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
CGMP Deviations: lack of adequate release testing.
Class II
Drug Recall · November 11, 2024
Safecor Health, LLC
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II
Drug Recall · November 11, 2024
American Regent, Inc.
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II
Drug Recall · November 11, 2024
American Regent, Inc.
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II
Drug Recall · November 11, 2024
Safecor Health, LLC
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II
Drug Recall · November 11, 2024
Safecor Health, LLC
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II
Drug Recall · November 11, 2024
American Regent, Inc.
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II
Drug Recall · November 11, 2024
Safecor Health, LLC
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II
Drug Recall · November 11, 2024
Safecor Health, LLC
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II
Drug Recall · November 8, 2024
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road
Subpotent drug
Class II
Drug Recall · November 7, 2024
Aurobindo Pharma USA Inc
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hights
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II
Drug Recall · November 7, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
Failed Impurity/Degradation Specifications
Class II
Drug Recall · November 7, 2024
Aurobindo Pharma USA Inc
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hight
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II
Drug Recall · November 7, 2024
Aurobindo Pharma USA Inc
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hight
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II
Drug Recall · November 7, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
Failed Impurity/Degradation Specifications
Class II
Drug Recall · November 6, 2024
Midlab Incorporated
Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II
Drug Recall · November 6, 2024
Midlab Incorporated
MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II
Drug Recall · November 6, 2024
Midlab Incorporated
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II
Drug Recall · November 6, 2024
Trinity Gold Nutrition
Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Class II
Drug Recall · November 6, 2024
Midlab Incorporated
Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II
Drug Recall · November 6, 2024
Tailstorm Health INC
BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1
Lack of Sterility Assurance
Class II
Drug Recall · November 6, 2024
Midlab Incorporated
boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II
Drug Recall · November 6, 2024
Midlab Incorporated
Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II
Drug Recall · November 5, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Class III
Drug Recall · November 4, 2024
Boulla LLC
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I
Drug Recall · November 4, 2024
Boulla LLC
ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I
Drug Recall · November 4, 2024
Boulla LLC
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I
Drug Recall · November 4, 2024
Boulla LLC
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I
Drug Recall · November 1, 2024
JR Watkins
Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05
cGMP Deviations
Class II
Drug Recall · November 1, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pit
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Drug Recall · November 1, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Drug Recall · November 1, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pi
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Drug Recall · November 1, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of In
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Drug Recall · November 1, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pi
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Drug Recall · November 1, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Drug Recall · October 31, 2024
Noven Pharmaceuticals Inc
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, M
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Class II
Drug Recall · October 30, 2024
Baxter Healthcare Corporation
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Hea
Labeling: Missing Label
Class II
Drug Recall · October 29, 2024
VIONA PHARMACEUTICALS INC
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
Crystallization
Class II
Drug Recall · October 29, 2024
FDC Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jerse
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II
Drug Recall · October 29, 2024
Dr. Reddy's Laboratories, Inc.
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
Failed Tablet/Capsule Specifications
Class III
Drug Recall · October 25, 2024
Lannett Company Inc.
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6
cGMP Deviations
Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6
cGMP Deviations
Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 00818 1
cGMP Deviations
Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0
cGMP Deviations
Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-71
cGMP Deviations
Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healt
cGMP Deviations
Class II