Esomeprazole Magnesium Recall for Failed Out-of-Specification Degradation Products
Zydus Pharmaceuticals is recalling Esomeprazole Magnesium oral suspension nationwide due to out-of-specification degradation products discovered during 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: This is an FDA Class II pharmaceutical recall for out-of-specification degradation products discovered during stability testing, with no reported illnesses or injuries. The recall is precautionary and based on failed quality specifications.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, in single-dose sachets. The affected product has been distributed nationwide in the United States under NDC 68382-848-94.
The recall was initiated due to failed quality specifications discovered during long-term stability testing. Testing revealed out-of-specification degradation products—specifically, unknown individual degradation products that exceeded acceptable limits during Related Compounds testing. These products did not meet the manufacturer's purity standards.
The recalled product is a prescription medication (Rx Only) manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals (USA) Inc. in Pennington, New Jersey. The recall includes approximately 22,152 units across multiple lot numbers with expiration dates ranging from July 2025 through November 2026.
The recalled product
- Product
- ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug
- Hazard
- degradation-product
- impurity
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.
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