The Recall Desk
SevereFDA (Drugs)·D-0442-2025·Announced 2025-05-28

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Category
Drug — Prescription / Gastrointestinal
Hazard

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

Same brand · ESOMEPRAZOLE MAGNESIUM

Same manufacturer · Zydus Pharmaceuticals (USA) Inc

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Same hazard · degradation product

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