FDA & USDA Recalls

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Current View: Drugs • Showing 50 recalls
Saline Nasal Spray
RECALLWebsite NoticeOngoing
Above acceptable microbiological limits for yeast and may contain Aspergillus spp.
Date: 06-11-2026|Location: N/A
ChloraPrep Clear – 1 mL Applicators and ChloraPrep FREPP Clear 1.5 mL Applicators
RECALLWebsite NoticeOngoing
Potential fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides
Date: 06-07-2026|Location: N/A
Gass-X Extra Strength Softgels 120 and 72ct
RECALLWebsite NoticeOngoing
Potential chemical contamination
Date: 06-03-2026|Location: N/A
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.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0579-2026
TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-22.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0578-2026
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0577-2026
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0576-2026
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.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0575-2026
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.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0574-2026
H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC 37808-136-22.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0573-2026
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.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0572-2026
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0571-2026
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.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0570-2026
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.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0569-2026
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., NDC 55319-171-68.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0568-2026
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0567-2026
CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0566-2026
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.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0565-2026
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.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0564-2026
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.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0563-2026
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.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0562-2026
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.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0561-2026
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.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0560-2026
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0559-2026
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0558-2026
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 Corporation, 999 Lake Drive, Issaquah, WA 98027, NDC 63981-171-80
RECALLClass IIOngoing
Presence of foreign substance: small metallic particles in chewable tablets.
Date: 05-28-2026|Location: N/A|Recall No: D-0557-2026
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.
RECALLClass IIOngoing
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Date: 05-27-2026|Location: N/A|Recall No: D-0584-2026
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 89113, NDC 72245-058-10
RECALLNot Yet ClassifiedOngoing
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
Date: 05-22-2026|Location: N/A
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
RECALLClass IIIOngoing
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Date: 05-18-2026|Location: N/A|Recall No: D-0552-2026
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.
RECALLClass IIIOngoing
Failed Stability Specifications
Date: 05-18-2026|Location: N/A|Recall No: D-0551-2026
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.
RECALLClass IIOngoing
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Date: 05-14-2026|Location: N/A|Recall No: D-0555-2026
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.
RECALLClass IIIOngoing
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Date: 05-14-2026|Location: N/A|Recall No: D-0550-2026
DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL
RECALLWebsite NoticeOngoing
Presence of glass particles
Date: 05-12-2026|Location: N/A
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.
RECALLClass IIOngoing
Lack of Assurance of Sterility
Date: 05-12-2026|Location: N/A|Recall No: D-0554-2026
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.
RECALLClass IIOngoing
Subpotent Drug
Date: 05-12-2026|Location: N/A|Recall No: D-0548-2026
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
RECALLClass IIOngoing
Defective Container; packets were found to be either empty or partially full.
Date: 05-12-2026|Location: N/A|Recall No: D-0543-2026
Multi-symptom Treatment Cream & Skin Protectant Eczema Cream, 6oz tube
RECALLWebsite NoticeOngoing
Contaminated with Staphylococcus aureus.
Date: 05-11-2026|Location: N/A
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
RECALLClass IIOngoing
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Date: 05-11-2026|Location: N/A|Recall No: D-0542-2026
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 cartons, STARTER KIT, NDC 50474-710-81.
RECALLClass IIOngoing
Lack of Assurance of Sterility
Date: 05-08-2026|Location: N/A|Recall No: D-0546-2026
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 67877-501-30.
RECALLClass IIOngoing
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Date: 05-05-2026|Location: N/A|Recall No: D-0556-2026
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.
RECALLClass IIIOngoing
Failed Impurities/Degradation Specifications
Date: 05-04-2026|Location: N/A|Recall No: D-0539-2026
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. NDC 54859-0516-08
RECALLClass IIOngoing
Presence of a Foreign Substance; black particles observed in liquid
Date: 05-01-2026|Location: N/A|Recall No: D-0549-2026
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 NDC: 68084-202-11
RECALLClass IIIOngoing
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Date: 05-01-2026|Location: N/A|Recall No: D-0537-2026
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
RECALLClass IIIOngoing
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Date: 05-01-2026|Location: N/A|Recall No: D-0536-2026
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01
RECALLClass IIOngoing
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Date: 04-30-2026|Location: N/A|Recall No: D-0538-2026
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).
RECALLClass IIOngoing
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Date: 04-29-2026|Location: N/A|Recall No: D-0545-2026
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).
RECALLClass IIOngoing
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Date: 04-29-2026|Location: N/A|Recall No: D-0544-2026
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
RECALLClass IIOngoing
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Date: 04-29-2026|Location: N/A|Recall No: D-0516-2026
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
RECALLClass IIOngoing
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Date: 04-29-2026|Location: N/A|Recall No: D-0515-2026
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India
RECALLClass IIOngoing
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Date: 04-29-2026|Location: N/A|Recall No: D-0514-2026