Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg recall
FDA recall D-0102-2025 · initiated Nov 14, 2024
Zydus Pharmaceuticals (USA) Inc recalled Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg in Nov 2024 — an FDA Class III recall (D-0102-2025) because Labeling: Not Elsewhere Classified - Wrong NDC number.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Not Elsewhere Classified - Wrong NDC number
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4404 packs
Details
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
- Recalling company
- Zydus Pharms
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide.
- Initiated
- Nov 14, 2024
- FDA report date
- Dec 11, 2024
Frequently asked
- Was Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg in Nov 2024 — an FDA Class III recall (D-0102-2025) because Labeling: Not Elsewhere Classified - Wrong NDC number. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0102-2025 was: Labeling: Not Elsewhere Classified - Wrong NDC number
- Is a recalled Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg are affected?
- Distributed: USA Nationwide.. The recall covers these lots — Lot#: M408002, Exp 05/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0102-2025.