Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Zydus Pharmaceuticals (USA) Inc

NDC code

68382-849-94

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0102-2025

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 Dec 19, 2025

INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato…

Reason Failed Disintegration Specifications: above the time expected.

Sato Pharmaceutical Co., Ltd NDC 49873-402-01 D-0298-2026

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