{"source":"fda-drug-recalls","note":"Free 5-item preview. The full feed is $0.05/call at GET /v1/fda-drug-recalls/changes.","question":"Which FDA drug recalls / enforcement actions were reported since T, and how serious (recall class) are they?","sample":[{"source":"fda-drug-recalls","entityId":"fda-drug-recalls:D-0555-2026","type":"recall","title":"Class II: Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76 (Asclemed USA Inc.)","summary":"CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. Distribution: US Nationwide.. Status: Ongoing (Voluntary: Firm initiated).","significance":6,"detectedAt":"2026-07-14T22:21:20.737Z","effectiveDate":"2026-05-14","sourceUrl":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0555-2026%22","detail":{"classification":"Class II","firm":"Asclemed USA Inc.","status":"Ongoing","voluntaryMandated":"Voluntary: Firm initiated","state":"CA","country":"United States"}},{"source":"fda-drug-recalls","entityId":"fda-drug-recalls:D-0556-2026","type":"recall","title":"Class II: Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd (Ascend Laboratories, LLC)","summary":"Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications Distribution: U.S.A. Nationwide. Status: Ongoing (Voluntary: Firm initiated).","significance":6,"detectedAt":"2026-07-14T22:21:20.737Z","effectiveDate":"2026-05-05","sourceUrl":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0556-2026%22","detail":{"classification":"Class II","firm":"Ascend Laboratories, LLC","status":"Ongoing","voluntaryMandated":"Voluntary: Firm initiated","state":"NJ","country":"United States"}},{"source":"fda-drug-recalls","entityId":"fda-drug-recalls:D-0562-2026","type":"recall","title":"Class II: Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COM (Guardian Drug Co. Inc.)","summary":"Presence of foreign substance: small metallic particles in chewable tablets. Distribution: U.S.A. Nationwide. Status: Ongoing (Voluntary: Firm initiated).","significance":6,"detectedAt":"2026-07-14T22:21:20.737Z","effectiveDate":"2026-05-28","sourceUrl":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0562-2026%22","detail":{"classification":"Class II","firm":"Guardian Drug Co. Inc.","status":"Ongoing","voluntaryMandated":"Voluntary: Firm initiated","state":"NJ","country":"United States"}},{"source":"fda-drug-recalls","entityId":"fda-drug-recalls:D-0598-2026","type":"recall","title":"Class II: Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc (SUN PHARMACEUTICAL INDUSTRIES INC)","summary":"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 Distribution: Nationwide within the United States. Status: Ongoing (Voluntary: Firm initiated).","significance":6,"detectedAt":"2026-07-14T22:21:20.737Z","effectiveDate":"2026-05-22","sourceUrl":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0598-2026%22","detail":{"classification":"Class II","firm":"SUN PHARMACEUTICAL INDUSTRIES INC","status":"Ongoing","voluntaryMandated":"Voluntary: Firm initiated","state":"NJ","country":"United States"}},{"source":"fda-drug-recalls","entityId":"fda-drug-recalls:D-0561-2026","type":"recall","title":"Class II: Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisour (Guardian Drug Co. Inc.)","summary":"Presence of foreign substance: small metallic particles in chewable tablets. Distribution: U.S.A. Nationwide. Status: Ongoing (Voluntary: Firm initiated).","significance":6,"detectedAt":"2026-07-14T22:21:20.737Z","effectiveDate":"2026-05-28","sourceUrl":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0561-2026%22","detail":{"classification":"Class II","firm":"Guardian Drug Co. Inc.","status":"Ongoing","voluntaryMandated":"Voluntary: Firm initiated","state":"NJ","country":"United States"}}]}