Drug Recalls

1,822 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 51–100 of 1,822

Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN, IRVING, TX 75063, UPC 0 5254863573 2.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-595-23.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-106-80.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
CareFusion 213, LLC
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subs
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., UP: 0 32251-92282-4.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporat
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
CareFusion 213, LLC
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsi
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class I
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COMPANY, ANKENY, IA 50521, UPC: 0 98437 24361 9.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129-68.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 27, 2026
Ajanta Pharma USA Inc
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Class II
Drug Recall · May 27, 2026
Glenmark Pharmaceuticals Inc., USA
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glen
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Class II
Drug Recall · May 27, 2026
Lannett Company Inc.
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Class II
Drug Recall · May 22, 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Class II
Drug Recall · May 22, 2026
Zep Inc
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-1
Microbial contamination of sterile products
Class II
Drug Recall · May 22, 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Class II
Drug Recall · May 21, 2026
Keystone Industries
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.
Defective container:may contain bottles with incomplete seals
Class II
Drug Recall · May 21, 2026
Keystone Industries
DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 696
Defective container:may contain bottles with incomplete seals
Class II
Drug Recall · May 21, 2026
Keystone Industries
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30
Defective container:may contain bottles with incomplete seals
Class II
Drug Recall · May 21, 2026
Keystone Industries
Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3.
Defective container:may contain bottles with incomplete seals
Class II
Drug Recall · May 21, 2026
Keystone Industries
Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30
Defective container:may contain bottles with incomplete seals
Class II
Drug Recall · May 21, 2026
Keystone Industries
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC
Defective container:may contain bottles with incomplete seals
Class II
Drug Recall · May 21, 2026
Keystone Industries
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30
Defective container:may contain bottles with incomplete seals
Class II
Drug Recall · May 18, 2026
IntegraDose Compounding Services LLC
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.
Subpotent Drug
Class II
Drug Recall · May 18, 2026
Eugia US LLC
Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class III
Drug Recall · May 18, 2026
AbbVie Inc.
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.
Failed Stability Specifications
Class III
Drug Recall · May 18, 2026
PReye LLC
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Lack of Assurance of Sterility
Class II
Drug Recall · May 15, 2026
PAI Holdings LLC
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08.
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II
Drug Recall · May 15, 2026
PAI Holdings LLC
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-2
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II
Drug Recall · May 15, 2026
PAI Holdings LLC
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04.
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II
Drug Recall · May 15, 2026
PAI Holdings LLC
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-2
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II
Drug Recall · May 14, 2026
AVEVA Drug Delivery Systems, Inc.
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Class III
Drug Recall · May 14, 2026
Asclemed USA Inc.
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Class II
Drug Recall · May 14, 2026
Fresenius Kabi USA, LLC
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Failed Impurities/Degradations Specifications
Class III
Drug Recall · May 12, 2026
SUN PHARMACEUTICAL INDUSTRIES INC
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical
Presence of Particulate matter: Particulate matter identified as glass.
Class I
Drug Recall · May 12, 2026
ANI Pharmaceuticals, Inc.
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
Defective Container; packets were found to be either empty or partially full.
Class II
Drug Recall · May 12, 2026
IntegraDose Compounding Services LLC
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.
Subpotent Drug
Class II
Drug Recall · May 12, 2026
Spectra Medical Devices, Llc
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.
Lack of Assurance of Sterility
Class II
Drug Recall · May 11, 2026
Haleon US Holdings LLC
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Class II
Drug Recall · May 8, 2026
UCB Biosciences Inc.
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 ca
Lack of Assurance of Sterility
Class II
Drug Recall · May 5, 2026
Ascend Laboratories, LLC
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 6
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Class II
Drug Recall · May 4, 2026
Sagent Pharmaceuticals
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.
Failed Impurities/Degradation Specifications
Class III
Drug Recall · May 1, 2026
Safecor Health, LLC
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH.
Presence of a Foreign Substance; black particles observed in liquid
Class II
Drug Recall · May 1, 2026
Amerisource Health Services LLC
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III