Drugs
FDA
2026-06-10
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Spectra Medical Devices, Llc
Hazard: Lack of Assurance of Sterility
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Spectra Medical Devices, Llc.
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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
Brand: Eugia Us Llc
Hazard: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
What to do: Class III recall (Ongoing). Stop using / discard the affected lot; contact Eugia Us Llc.
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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
Brand: Sun Pharmaceutical Industries Inc
Hazard: 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
What to do: Not Yet Classified recall (Ongoing). Stop using / discard the affected lot; contact Sun Pharmaceutical Industries Inc.
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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
Brand: Ascend Laboratories, Llc
Hazard: Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Ascend Laboratories, Llc.
Drugs
FDA
2026-06-10
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.
Brand: Asclemed Usa Inc.
Hazard: CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Asclemed Usa Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-10
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.
Brand: Lannett Company Inc.
Hazard: Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Lannett Company Inc..
Drugs
FDA
2026-06-10
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
Brand: Guardian Drug Co. Inc.
Hazard: Presence of foreign substance: small metallic particles in chewable tablets.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Guardian Drug Co. Inc..
Drugs
FDA
2026-06-03
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.
Brand: Aveva Drug Delivery Systems, Inc.
Hazard: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
What to do: Class III recall (Ongoing). Stop using / discard the affected lot; contact Aveva Drug Delivery Systems, Inc..
Drugs
FDA
2026-06-03
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.
Brand: Abbvie Inc.
Hazard: Failed Stability Specifications
What to do: Class III recall (Ongoing). Stop using / discard the affected lot; contact Abbvie Inc..
Drugs
FDA
2026-05-27
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
Brand: Safecor Health, Llc
Hazard: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Safecor Health, Llc.
Drugs
FDA
2026-05-27
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.
Brand: Integradose Compounding Services Llc
Hazard: Subpotent Drug
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Integradose Compounding Services Llc.
Drugs
FDA
2026-05-27
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; (
Brand: Zydus Pharmaceuticals (Usa) Inc
Hazard: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Zydus Pharmaceuticals (Usa) Inc.
Drugs
FDA
2026-05-27
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02
Brand: Lupin Pharmaceuticals Inc.
Hazard: Presence of particulate matter: a white thread-like structure in the cartridge
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Lupin Pharmaceuticals Inc..
Drugs
FDA
2026-05-27
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
Brand: Zydus Pharmaceuticals (Usa) Inc
Hazard: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Zydus Pharmaceuticals (Usa) Inc.
Drugs
FDA
2026-05-27
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
Brand: Amerisource Health Services Llc
Hazard: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
What to do: Class III recall (Ongoing). Stop using / discard the affected lot; contact Amerisource Health Services Llc.
Drugs
FDA
2026-05-27
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05
Brand: Golden State Medical Supply Inc.
Hazard: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
What to do: Class III recall (Ongoing). Stop using / discard the affected lot; contact Golden State Medical Supply Inc..
Drugs
FDA
2026-05-27
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
Brand: Golden State Medical Supply Inc.
Hazard: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
What to do: Class III recall (Ongoing). Stop using / discard the affected lot; contact Golden State Medical Supply Inc..
Drugs
FDA
2026-05-27
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
Brand: Wisconsin Pharmacal Company
Hazard: Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
What to do: Class I recall (Ongoing). Stop using / discard the affected lot; contact Wisconsin Pharmacal Company.