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.
What this means for you
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.
Related recalls
Same brand · ESOMEPRAZOLE MAGNESIUM
- SevereEsomeprazole Magnesium Oral Suspension Recalled for Failed Impurity Specifications
FDA (Drugs) · 2025-05-28
- ModerateEsomeprazole Magnesium oral suspension recalled for failed impurity specifications
FDA (Drugs) · 2025-05-28
- ModeratePrescription esomeprazole magnesium capsules recalled for failed impurity specifications
FDA (Drugs) · 2023-11-29
- ModeratePrescription Drug Esomeprazole Out of Specification for Potency
FDA (Drugs) · 2022-10-05
- ModerateEsomeprazole Magnesium Capsules Recalled for Out-of-Specification Potency
FDA (Drugs) · 2022-10-05
Same manufacturer · Zydus Pharmaceuticals (USA) Inc
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- SevereErythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
- HighIcosapent ethyl capsules recalled after active ingredient oxidized inside capsule
FDA (Drugs) · 2026-03-18
- HighIcosapent ethyl capsules recalled as subpotent after capsule contents leaked
FDA (Drugs) · 2026-01-28
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02