Reported Dec 11, 2024 · Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by:…
Zydus Pharmaceuticals (USA) Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only
- Manufactured byZydus Lifesciences Ltd. Ahmedabad, India
- Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
- Lot codes and dates
Lot#: M408002Exp 05/31/2026
- Amount recalled
- 4404 packs
Where it was sold
- Nationwide
Why it was recalled
Labeling: Not Elsewhere Classified - Wrong NDC number
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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