FDA Drug Regulatory Intelligence — Recalls & Shortages https://fdadri.com/ Latest U.S. FDA drug recalls and shortages. Regulatory information only — not medical advice. en-US Tue, 09 Jun 2026 16:46:18 GMT Shortage (Discontinued): Dacomitinib Tablet https://fdadri.com/drug-shortages/dacomitinib-tablet-discontinued https://fdadri.com/drug-shortages/dacomitinib-tablet-discontinued FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Discontinued): Dacomitinib Tablet https://fdadri.com/drug-shortages/dacomitinib-tablet-discontinued-2 https://fdadri.com/drug-shortages/dacomitinib-tablet-discontinued-2 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Liraglutide Injection https://fdadri.com/drug-shortages/liraglutide-injection-current https://fdadri.com/drug-shortages/liraglutide-injection-current FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet https://fdadri.com/drug-shortages/amphetamine-aspartate-monohydrate-amphetamine-sulfate-dextroamphetamine-saccharate-dextroamphetamine-sulfate-tablet-current https://fdadri.com/drug-shortages/amphetamine-aspartate-monohydrate-amphetamine-sulfate-dextroamphetamine-saccharate-dextroamphetamine-sulfate-tablet-current FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Lisdexamfetamine Dimesylate Tablet, Chewable https://fdadri.com/drug-shortages/lisdexamfetamine-dimesylate-tablet-chewable-current https://fdadri.com/drug-shortages/lisdexamfetamine-dimesylate-tablet-chewable-current FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Cromolyn Sodium Concentrate https://fdadri.com/drug-shortages/cromolyn-sodium-concentrate-current https://fdadri.com/drug-shortages/cromolyn-sodium-concentrate-current FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Lisdexamfetamine Dimesylate Tablet, Chewable https://fdadri.com/drug-shortages/lisdexamfetamine-dimesylate-tablet-chewable-current-2 https://fdadri.com/drug-shortages/lisdexamfetamine-dimesylate-tablet-chewable-current-2 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Discontinued): Dacomitinib Tablet https://fdadri.com/drug-shortages/dacomitinib-tablet-discontinued-3 https://fdadri.com/drug-shortages/dacomitinib-tablet-discontinued-3 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Azacitidine Injection https://fdadri.com/drug-shortages/azacitidine-injection-current https://fdadri.com/drug-shortages/azacitidine-injection-current FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Rifampin Capsule https://fdadri.com/drug-shortages/rifampin-capsule-current https://fdadri.com/drug-shortages/rifampin-capsule-current FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Discontinued): Leflunomide Tablet https://fdadri.com/drug-shortages/leflunomide-tablet-discontinued https://fdadri.com/drug-shortages/leflunomide-tablet-discontinued FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Bumetanide Injection https://fdadri.com/drug-shortages/bumetanide-injection-current https://fdadri.com/drug-shortages/bumetanide-injection-current FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Lisdexamfetamine Dimesylate Tablet, Chewable https://fdadri.com/drug-shortages/lisdexamfetamine-dimesylate-tablet-chewable-current-3 https://fdadri.com/drug-shortages/lisdexamfetamine-dimesylate-tablet-chewable-current-3 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Bumetanide Injection https://fdadri.com/drug-shortages/bumetanide-injection-current-2 https://fdadri.com/drug-shortages/bumetanide-injection-current-2 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Bumetanide Injection https://fdadri.com/drug-shortages/bumetanide-injection-current-3 https://fdadri.com/drug-shortages/bumetanide-injection-current-3 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Rifampin Capsule https://fdadri.com/drug-shortages/rifampin-capsule-current-2 https://fdadri.com/drug-shortages/rifampin-capsule-current-2 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Bumetanide Injection https://fdadri.com/drug-shortages/bumetanide-injection-current-4 https://fdadri.com/drug-shortages/bumetanide-injection-current-4 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Liraglutide Injection https://fdadri.com/drug-shortages/liraglutide-injection-current-2 https://fdadri.com/drug-shortages/liraglutide-injection-current-2 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Rifampin Capsule https://fdadri.com/drug-shortages/rifampin-capsule-current-3 https://fdadri.com/drug-shortages/rifampin-capsule-current-3 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet https://fdadri.com/drug-shortages/amphetamine-aspartate-monohydrate-amphetamine-sulfate-dextroamphetamine-saccharate-dextroamphetamine-sulfate-tablet-current-2 https://fdadri.com/drug-shortages/amphetamine-aspartate-monohydrate-amphetamine-sulfate-dextroamphetamine-saccharate-dextroamphetamine-sulfate-tablet-current-2 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Rifampin Capsule https://fdadri.com/drug-shortages/rifampin-capsule-current-4 https://fdadri.com/drug-shortages/rifampin-capsule-current-4 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Cromolyn Sodium Concentrate https://fdadri.com/drug-shortages/cromolyn-sodium-concentrate-current-2 https://fdadri.com/drug-shortages/cromolyn-sodium-concentrate-current-2 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Lisdexamfetamine Dimesylate Tablet, Chewable https://fdadri.com/drug-shortages/lisdexamfetamine-dimesylate-tablet-chewable-current-4 https://fdadri.com/drug-shortages/lisdexamfetamine-dimesylate-tablet-chewable-current-4 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Discontinued): Leflunomide Tablet https://fdadri.com/drug-shortages/leflunomide-tablet-discontinued-2 https://fdadri.com/drug-shortages/leflunomide-tablet-discontinued-2 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Shortage (Current): Liraglutide Injection https://fdadri.com/drug-shortages/liraglutide-injection-current-3 https://fdadri.com/drug-shortages/liraglutide-injection-current-3 FDA drug-shortage record (regulatory supply information, not medical advice). Mon, 08 Jun 2026 00:00:00 GMT Recall (Class III): 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. https://fdadri.com/drug-recalls/d-0550-2026 https://fdadri.com/drug-recalls/d-0550-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 03 Jun 2026 00:00:00 GMT Recall (Class III): 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. https://fdadri.com/drug-recalls/d-0551-2026 https://fdadri.com/drug-recalls/d-0551-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 03 Jun 2026 00:00:00 GMT Recall (Class II): 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 https://fdadri.com/drug-recalls/d-0538-2026 https://fdadri.com/drug-recalls/d-0538-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT Recall (Class II): 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. https://fdadri.com/drug-recalls/d-0548-2026 https://fdadri.com/drug-recalls/d-0548-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT Recall (Class II): 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). https://fdadri.com/drug-recalls/d-0545-2026 https://fdadri.com/drug-recalls/d-0545-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT Recall (Class II): 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; b) 3 Pens - NDC 70748-346-03. https://fdadri.com/drug-recalls/d-0541-2026 https://fdadri.com/drug-recalls/d-0541-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT Recall (Class II): 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). https://fdadri.com/drug-recalls/d-0544-2026 https://fdadri.com/drug-recalls/d-0544-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT Recall (Class III): 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 https://fdadri.com/drug-recalls/d-0537-2026 https://fdadri.com/drug-recalls/d-0537-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT Recall (Class III): 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 https://fdadri.com/drug-recalls/d-0534-2026 https://fdadri.com/drug-recalls/d-0534-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT Recall (Class III): 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 https://fdadri.com/drug-recalls/d-0535-2026 https://fdadri.com/drug-recalls/d-0535-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT Recall (Class I): 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. https://fdadri.com/drug-recalls/d-0553-2026 https://fdadri.com/drug-recalls/d-0553-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT Recall (Class II): 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. https://fdadri.com/drug-recalls/d-0546-2026 https://fdadri.com/drug-recalls/d-0546-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT Recall (Class III): 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 https://fdadri.com/drug-recalls/d-0536-2026 https://fdadri.com/drug-recalls/d-0536-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT Recall (Class II): 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 https://fdadri.com/drug-recalls/d-0543-2026 https://fdadri.com/drug-recalls/d-0543-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT Recall (Class III): 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. https://fdadri.com/drug-recalls/d-0539-2026 https://fdadri.com/drug-recalls/d-0539-2026 FDA drug recall enforcement report (regulatory information, not medical advice). Wed, 27 May 2026 00:00:00 GMT