Esomeprazole Magnesium Oral Suspension Recalled for Degradation Products
Zydus Pharmaceuticals is recalling specific lots of Esomeprazole Magnesium 40 mg delayed-release oral suspension due to out-of-specification degradation products detected during stability testing.
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: FDA Class II recall for out-of-specification degradation products in a prescription medication. No illnesses or injuries reported. Qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling specific lots of Esomeprazole Magnesium 40 mg for Delayed-Release Oral Suspension. The affected lots are: M311638 (expires July 2025), M400374 (expires October 2025), M402496 (expires February 2026), M407998 (expires May 2026), M502247 (expires November 2026), M414770 (expires September 2026), and M414512 (expires September 2026). Approximately 30,674 sachets have been distributed nationwide.
During long-term stability testing, out-of-specification degradation products were detected in the affected lots that did not meet required specifications. No patient illnesses or injuries have been reported.
Patients and healthcare providers with affected lots should discontinue use and contact their healthcare provider or pharmacy for alternative treatment options.
The recalled product
- Product
- ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Proton Pump Inhibitor
- Hazard
- degradation-products
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 (13)
- Lot # M311638
- Exp 07/2025
- M400374
- Exp 10/2025
- M402496
- Exp 02/2026
- M407998
- Exp 05/2026
- M502247
- Exp 11/2026
- M414770
- M414512
- Exp 09/2026.
Distribution
Distributed nationwide across the United States.
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