FDA Enforcement Records
Explore FDA enforcement records
Browse published US FDA drug-enforcement recall records. Filter by country, classification, status, or date.
Showing 251–275 of 5,012 active FDA enforcement records
- View firm →Class IIOngoingAlyacen 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: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29 · Jun 24, 2026 · United States
- View firm →Class IOngoingBEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789. · Jun 17, 2026 · United States
- View firm →Class IIOngoingBudesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49. · Jun 17, 2026 · United States
- View firm →Class IIOngoingMinocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30 · Jun 17, 2026 · United States
- View firm →Class IOngoingGas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059. · Jun 17, 2026 · United States
- View firm →Class IIOngoingGSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90. · Jun 17, 2026 · United States
- View firm →Class IIOngoingZep, 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 66949-133-85. · Jun 17, 2026 · United States
- View firm →Class IIIOngoingPrimidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01 · Jun 17, 2026 · United States
- View firm →Class IIOngoingDuloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. · Jun 17, 2026 · United States
- View firm →Class IIOngoingDuloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 · Jun 17, 2026 · United States
- View firm →Class IIIOngoingEpinephrine 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) · Jun 17, 2026 · United States
- View firm →Class IOngoingDOXOrubin 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 Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01. · Jun 17, 2026 · United States
- View firm →Class IIOngoingXyvona (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 · Jun 10, 2026 · United States
- View firm →Class IIOngoingXyvona (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 89113, NDC 72245-762-10 · Jun 10, 2026 · United States
- View firm →Class IIOngoingNiacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46. · Jun 10, 2026 · United States
- View firm →Class IIOngoingTopCare 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. · Jun 10, 2026 · United States
- View firm →Class IIOngoingTopCare 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. · Jun 10, 2026 · United States
- View firm →Class IIOngoingEQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68. · Jun 10, 2026 · United States
- View firm →Class IIOngoingEQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22. · Jun 10, 2026 · United States
- View firm →Class IIOngoingGOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68. · Jun 10, 2026 · United States
- View firm →Class IIOngoingGOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22. · Jun 10, 2026 · United States
- View firm →Class IIOngoingH.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. · Jun 10, 2026 · United States
- View firm →Class IIOngoingHyVee, 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. · Jun 10, 2026 · United States
- View firm →Class IIOngoingHyVee, 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. · Jun 10, 2026 · United States
- View firm →Class IIOngoingHarris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1. · Jun 10, 2026 · United States
Only the latest five years of published US FDA drug-enforcement recall records are indexed. The displayed entity is an FDA-recorded recalling firm; country, city, and state are source attributes, not proof of manufacturer, parent company, ownership, legal entity, safety, compliance, or approval.