Drug FDA Class III Ongoing Mislabeling

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

Zydus Pharmaceuticals (USA) Inc Published Dec 11, 2024

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Zydus Pharmaceuticals (USA) Inc or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Labeling: Not Elsewhere Classified - Wrong NDC number

Affected products (1)

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

ESOMEPRAZOLE MAGNESIUM · 4404 packs

NDC: 68382-848, 68382-849, 68382-848-94, 68382-849-94

Code info: Lot#: M408002, Exp 05/31/2026

Affected areas

Nationwide

Timeline

Initiated

Nov 14, 2024
Published

Dec 11, 2024

Recall number: D-0102-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.