Drug Recalls

1,842 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 1,601–1,650 of 1,842

Drug Recall · February 20, 2024
Eugia US LLC
Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II
Drug Recall · February 20, 2024
Eugia US LLC
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01
Failed Dissolution Specifications
Class II
Drug Recall · February 19, 2024
Seatex LLC
PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II
Drug Recall · February 19, 2024
Seatex LLC
PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II
Drug Recall · February 19, 2024
Seatex LLC
7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II
Drug Recall · February 19, 2024
Seatex LLC
7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II
Drug Recall · February 19, 2024
Seatex LLC
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX H
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II
Drug Recall · February 16, 2024
Global Corporation
Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc,
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class II
Drug Recall · February 16, 2024
Global Corporation
Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 US
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class II
Drug Recall · February 15, 2024
Eugia US LLC
Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10
Presence of Particulate Matter
Class I
Drug Recall · February 14, 2024
Golden State Medical Supply Inc.
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Class II
Drug Recall · February 13, 2024
Amneal Pharmaceuticals of New York, LLC
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class II
Drug Recall · February 12, 2024
FA Online Inc
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Class I
Drug Recall · February 12, 2024
Micro Labs Limited
Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01
CGMP Deviations: Out of specification for residual solvents.
Class II
Drug Recall · February 12, 2024
MCKESSON CORPORATION
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Br
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Class II
Drug Recall · February 9, 2024
Stason Pharmaceuticals, Inc.
Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.qui
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Class III
Drug Recall · February 9, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharm
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Class II
Drug Recall · February 9, 2024
Apotex Corp.
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 3332
CGMP Deviations: potential presence of Burkholderia cepacia complex
Class II
Drug Recall · February 9, 2024
Micro Labs Limited
Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.
Failed Stability Specifications: Out of specification for blend uniformity.
Class II
Drug Recall · February 7, 2024
Mckesson Medical-Surgical Inc. Corporate Office
Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
cGMP Deviations: Products were stored outside the drug label specifications.
Class II
Drug Recall · February 7, 2024
Mckesson Medical-Surgical Inc. Corporate Office
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
cGMP Deviations: Products were stored outside the drug label specifications.
Class II
Drug Recall · February 7, 2024
Mckesson Medical-Surgical Inc. Corporate Office
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
cGMP Deviations: Products were stored outside the drug label specifications.
Class II
Drug Recall · February 6, 2024
Today The World
Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class I
Drug Recall · February 6, 2024
Today The World
SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class I
Drug Recall · February 6, 2024
Today The World
Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class I
Drug Recall · February 6, 2024
Mallinckrodt Hospital Products Inc.
Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class II
Drug Recall · February 6, 2024
Mallinckrodt Hospital Products Inc.
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class II
Drug Recall · February 5, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
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,
Failed Dissolution Specifications: Out of specification for dissolution.
Class II
Drug Recall · February 5, 2024
Super Chill Products
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.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I
Drug Recall · February 5, 2024
Lupin Pharmaceuticals Inc.
Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously f
Labeling: Incorrect or Missing Package Insert
Class II
Drug Recall · February 2, 2024
Bausch Health Companies, Inc.
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
Subpotent Drug: Out of specification for assay
Class II
Drug Recall · February 1, 2024
NATCO Pharma Limited
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.
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Class II
Drug Recall · February 1, 2024
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
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
Chemical Contamination; presence of benzene.
Class I
Drug Recall · February 1, 2024
Amerisource Health Services LLC
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
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Class III
Drug Recall · February 1, 2024
Integrity Products
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
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I
Drug Recall · February 1, 2024
Integrity Products
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
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I
Drug Recall · January 30, 2024
Brassica Pharma Pvt Ltd
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
Lack of Assurance of Sterility
Class II
Drug Recall · January 30, 2024
Brassica Pharma Pvt Ltd
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
Lack of Assurance of Sterility
Class II
Drug Recall · January 30, 2024
Brassica Pharma Pvt Ltd
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
Lack of Assurance of Sterility
Class II
Drug Recall · January 30, 2024
Brassica Pharma Pvt Ltd
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
Lack of Assurance of Sterility
Class II
Drug Recall · January 25, 2024
Teva Pharmaceuticals USA, Inc
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
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III
Drug Recall · January 25, 2024
Amerisource Health Services LLC
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
CGMP Deviations
Class II
Drug Recall · January 25, 2024
Alpha Aromatics
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.
CGMP Deviations
Class II
Drug Recall · January 25, 2024
Teva Pharmaceuticals USA, Inc
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
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III
Drug Recall · January 23, 2024
Baxter Healthcare Corporation
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.
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Class II
Drug Recall · January 22, 2024
IntegraDose Compounding Services LLC
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
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Class II
Drug Recall · January 19, 2024
Bestco LLC
CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II
Drug Recall · January 19, 2024
OMEZA LLC
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
CGMP Deviations
Class II
Drug Recall · January 19, 2024
Bestco LLC
Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II
Drug Recall · January 19, 2024
Bestco LLC
Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II