Prescription drug esomeprazole magnesium recalled for labeling error
Zydus Pharmaceuticals is recalling esomeprazole magnesium oral suspension because of an incorrect NDC number on package labeling. The affected product is lot M408002 distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving a minor labeling error (incorrect NDC number). No illnesses, injuries, or health hazards have been reported.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling esomeprazole magnesium delayed-release oral suspension 40 mg due to a labeling error. The recalled product contains an incorrect NDC number printed on the packaging.
The affected product is esomeprazole magnesium 40 mg delayed-release oral suspension in single-dose sachets, lot M408002 with expiration date 05/31/2026. Approximately 4,404 packs were distributed nationwide in the United States under product NDC 68382-849-94.
The recalled product
- Product
- ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 4,404
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: M408002
- Exp 05/31/2026
Distribution
Distributed nationwide across the United States.
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