More Than 1.5 Million Packages of a Trusted Digestive Reliever Have Been Recalled Nationwide

It’s that uncomfortable sensation you can get after a particularly large meal or perhaps while trying to doze off at night: acid reflux. Heartburn, indigestion, and nausea are all possible symptoms when the stomach’s acid travels back up into the esophagus. And when acid reflux becomes a chronic occurrence, defined by the Cleveland Clinic as “at least twice a week for several weeks,” it becomes known as gastroesophageal reflux disease (GERD).

An estimated 20% of American adults—and 10% of children—experience GERD. Thankfully, a number of over-the-counter and prescription medications may ease discomfort…but the U.S. Food and Drug Administration (FDA) this week announced a popular prescription is facing a major recall.

In a report, the FDA says a total of 1,584,780 single-dose packages of Esomeprazole Magnesium for Delayed-Release Oral Suspension were recalled nationwide starting on May 13. Esomeprazole, sometimes known by the brand name Nexium, is prescribed for GERD, ulcers, or other health issues related to stomach acid.

“Failed Impurities/Degradation Specifications” is what the FDA reports prompted the recall event. Though it’s not immediately clear what the “failed impurities” were, the report goes on to note: “Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.”

The FDA, in a document discussing “Out-of-Specification” test results in pharmaceutical production, says “FDA regulations require that an investigation be conducted whenever an OOS test result is obtained.”

The report says the medication, available only via a prescription, came in single-dose packets inside cartons. A website for Nexium explains packet contents, mixed with water, offer an option for both adults and children who may struggle to swallow regular pills.

The full product details are:

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg

• 30-count Single-Dose Packets per carton, Rx Only
• Lot Codes and Expiration Dates:
  • 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
• Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India
• Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ
• 30,674 sachets per carton; 920,220 total sachets

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg

• 30-count single dose packets per carton, Rx Only
• Lot Codes and Expiration Dates:
  • M402147, Exp 10/2025
  • M311637, Exp 07/2025
  • M402495, Exp 02/2026
  • M407997, Exp 05/2026
  • M502246, Exp11/2026
• Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India
• Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ
• 22,152 sachets/carton; 664,560 total sachets

Though the recall apparently first went into effect last week on May 13, the FDA’s report wasn’t publicly available until Tuesday. That’s when the agency assigned a Class II designation to the event, meaning the products may cause temporary or medically reversible adverse health effects.

As the named recalling firm, distributor Zydus Pharmaceuticals (USA) Inc is “a leading generic pharmaceutical company” in the U.S., per its website. They are also a part of the global pharmaceutical company Zydus Lifesciences, which says it has a presence in 50 countries.

Zydus Lifescience Ltd. In India was also named in a prescription skincare product recall earlier this year.

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