Zydus Pharmaceuticals (USA) Inc is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg because the product labeling displays the wrong National Drug Code (NDC) number. The affected items are 30 single-dose packets distributed nationwide in the USA. The recall was initiated on November 14, 2024. Read more at govinfonow.com/recall/32436-zydus-recalls-esomeprazole-due-to-wrong-ndc-labeling.
“Zydus Recalls Esomeprazole Due to Wrong NDC Labeling.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32436-zydus-recalls-esomeprazole-due-to-wrong-ndc-labeling. Based on FDA recall #D-0102-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0102-2025%22&limit=1).
Zydus Pharmaceuticals (USA) Inc. recalled Esomeprazole Magnesium for Delayed-Release Oral Suspension due to a wrong NDC number on the labeling, the FDA said on Nov. 14, 2024.
The product carries the wrong NDC number on its labeling, according to the FDA.
Context
GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc. has 53 other recalls on record since March 14, 2012. Recent Zydus recalls include a Mirabegron recall on Aug. 5, 2026, an Erythromycin recall on April 29, 2026, and an Icosapent Ethyl recall on March 9, 2026. Other recent recalls of similar products include a Doxazosin recall by Unichem on Jan. 21, 2026, a Bisoprolol/Hydrochlorothiazide recall by Unichem on Jan. 21, 2026, and a Methylprednisolone recall by Greenstone on Jan. 15, 2026.
How to tell if you have this one
Look for Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg in 30 single-dose packets (sachets). Check if the NDC number is 68382-849-94 and the Lot Number is M408002 with an expiration date of 05/31/2026. The product was manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals (USA) Inc.
Brand
Zydus Pharmaceuticals
Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 27 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0102-2025 (November 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0102-2025 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.