FDA Drugs recall ·
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg… recall
- Recall number
- D-0443-2025
- Date
- (initiated May 13, 2025)
- Company / brand
- Zydus Pharmaceuticals (USA) Inc
73 Route 31 N, Pennington, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 22,152 30 sachets/carton
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 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 68382-848-94
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #:M402147, Exp 10/2025; M311637, Exp 07/2025; M402495, Exp 02/2026; M407997, Exp 05/2026; M502246, Exp11/2026.
Distribution
Nationwide -in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0443-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.