[pending] ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
Pending LLM rewrite. Source: FDA_DRUG D-0443-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
The recalled product
- Product
- ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Drugs
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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- 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
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