FDA Drugs recall ·
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg… recall
- Recall number
- D-0102-2025
- Date
- (initiated November 14, 2024)
- Company / brand
- Zydus Pharmaceuticals (USA) Inc
73 Route 31 N, Pennington, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 4404 packs
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
Why was it recalled?
Labeling: Not Elsewhere Classified - Wrong NDC number
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#: M408002, Exp 05/31/2026
Distribution
USA Nationwide.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0102-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.