Esomeprazole Magnesium oral suspension recalled for failed impurity specifications
Zydus Pharmaceuticals is recalling Esomeprazole Magnesium delayed-release oral suspension, 20 mg, due to out-of-specification test results for unknown degradation products detected during long-term stability testing.
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: The recall is classified as FDA Class II. The source text states failed impurity specifications without reporting any actual adverse events or hospitalizations. The hazard is based on out-of-specification test results in stability studies, not confirmed patient harm.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single-dose packets (NDC 68382-848-94). The recall was initiated because out-of-specification results were obtained for an unknown degradation product during Related Compounds testing in long-term stability studies.
The affected product was distributed nationwide in the United States. Consumers currently taking the recalled medication should contact their healthcare provider or pharmacist for guidance. Do not stop taking this medication without first speaking with a healthcare professional, as discontinuing esomeprazole without medical supervision may cause serious health effects.
The recalled product
- Product
- ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
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 (10)
- Lot #:M402147
- Exp 10/2025
- M311637
- Exp 07/2025
- M402495
- Exp 02/2026
- M407997
- Exp 05/2026
- M502246
- Exp11/2026.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zydus Pharmaceuticals (USA) Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · ESOMEPRAZOLE MAGNESIUM
- SevereEsomeprazole Magnesium Oral Suspension Recalled for Failed Impurity Specifications
FDA (Drugs) · 2025-05-28
- ModeratePrescription drug esomeprazole magnesium recalled for labeling error
FDA (Drugs) · 2024-12-11
- 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 · impurity degradation
See all →- Low
- HighDiltiazem Hydrochloride extended-release capsules recalled due to failed quality specifications
FDA (Drugs) · 2023-02-08
- ModerateXiidra ophthalmic solution recalled for failed impurity and degradation specifications
FDA (Drugs) · 2022-06-15
- ModerateXiidra Ophthalmic Solution Recalled for Failed Impurity and Degradation Specifications
FDA (Drugs) · 2022-06-15
- ModeratehydrALAZINE HCl Tablets 10 mg Recalled for Failed Impurity Specifications
FDA (Drugs) · 2022-03-23