Esomeprazole Magnesium Oral Suspension Recalled for Failed Impurity Specifications
Zydus Pharmaceuticals is recalling Esomeprazole Magnesium 40 mg delayed-release oral suspension because out-of-specification test results were found for unknown degradation products during stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall with an out-of-specification degradation product issue in a prescription drug affecting patient safety and product integrity, meeting the criteria for a Severe rating.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Esomeprazole Magnesium (Esomeprazole Magnesium) delayed-release oral suspension, 40 mg, supplied in 30-count single-dose packets per carton. The recall affects lot numbers M311638 (Exp 07/2025), M400374 (Exp 10/2025), M402496 (Exp 02/2026), M407998 (Exp 05/2026), M502247 (Exp 11/2026), M414770, and M414512 (Exp 09/2026), with a total of 30,674 cartons distributed nationwide in the USA.
The recall was initiated due to failed impurities and degradation specifications. Out-of-specification test results were obtained for unknown individual degradation products during related compounds testing in long-term stability studies.
Consumers taking this medication should contact their healthcare provider or pharmacist before discontinuing use or to discuss alternative treatment options. Patients should not stop taking their medication abruptly without consulting their healthcare provider. Inquiries can be directed to Zydus Pharmaceuticals (USA) Inc. at the contact information provided by the FDA.
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 (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.
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
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