Esomeprazole Magnesium for Delayed-Release Oral Suspension recall
FDA recall D-0442-2025 · initiated May 13, 2025
Zydus Pharmaceuticals (USA) Inc recalled Esomeprazole Magnesium for Delayed-Release Oral Suspension in May 2025 — an FDA Class II recall (D-0442-2025) because Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 30,674 30 sachets/carton
Details
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
- Recalling company
- Zydus Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide -in the USA
- Initiated
- May 13, 2025
- FDA report date
- May 28, 2025
Frequently asked
- Was Esomeprazole Magnesium for Delayed-Release Oral Suspension recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Esomeprazole Magnesium for Delayed-Release Oral Suspension in May 2025 — an FDA Class II recall (D-0442-2025) because Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Esomeprazole Magnesium for Delayed-Release Oral Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0442-2025 was: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
- Is a recalled Esomeprazole Magnesium for Delayed-Release Oral Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Esomeprazole Magnesium for Delayed-Release Oral Suspension are affected?
- Distributed: Nationwide -in the USA. The recall covers these lots — 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0442-2025.