Drug Recalls

1,842 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 1,251–1,300 of 1,842

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 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 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
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
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
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
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
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
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 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
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
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 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 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, 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
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 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 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
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
JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5
cGMP Deviations
Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%, Distributed by: Walmart Inc., Bentonville, AR 72716 NDC 79903-106-06
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
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
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
ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7
cGMP Deviations
Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9
cGMP Deviations
Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN
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 23, 2024
Lupin Pharmaceuticals Inc.
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimor
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II
Drug Recall · October 23, 2024
Lupin Pharmaceuticals Inc.
Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltim
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II
Drug Recall · October 23, 2024
Cipla USA, Inc.
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II
Drug Recall · October 23, 2024
Cipla USA, Inc.
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II
Drug Recall · October 23, 2024
Lupin Pharmaceuticals Inc.
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimo
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II
Drug Recall · October 22, 2024
Dr. Reddy's Laboratories, Inc.
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
Failed Impurities/Degradation Specification
Class II
Drug Recall · October 22, 2024
Dr. Reddy's Laboratories, Inc.
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
Failed Impurities/Degradation Specification
Class II
Drug Recall · October 21, 2024
BLI International, Inc.
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Class II
Drug Recall · October 18, 2024
AvKARE
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
Labeling: Label Mix-Up
Class II
Drug Recall · October 18, 2024
AvKARE
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Labeling: Label Mix-Up
Class II
Drug Recall · October 17, 2024
Keystone Industries
Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08
Subpotent Drug
Class II
Drug Recall · October 15, 2024
Akron Pharma, Inc.
OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06
CGMP Deviations
Class II