INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Sato Pharmaceutical Co., Ltd

NDC code

49873-402-01

Origin

N/A, Japan

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0298-2026

Other Magnesium recalls

See all

Class III · Low risk Ongoing Mar 31, 2026

Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance…

Reason Subpotent drug

Avantor Performance Materials LLC NDC 10106-2448-1 D-0488-2026

Class I · High risk Ongoing Mar 18, 2026

Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx…

Reason Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.

Amneal Pharmaceuticals, LLC NDC 70121-1720-3 D-0478-2026

Class II · Moderate risk Ongoing Jul 30, 2025

Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…

Reason Lack of Assurance of Sterility

GenoGenix LLC D-0062-2026

Class II · Moderate risk Ongoing Jul 30, 2025

Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…

Reason Lack of Assurance of Sterility

GenoGenix LLC D-0052-2026

Class II · Moderate risk Ongoing May 13, 2025

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured…

Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during…

Zydus Pharmaceuticals (USA) Inc NDC 68382-848-94 D-0443-2025