PlainRecalls
FDA Drug Moderate Class II Terminated

Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.

Reported: April 6, 2022 Initiated: March 23, 2022 #D-0738-2022

Product Description

Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.

Reason for Recall

Failed Dissolution Specifications; during long term stability testing.

Details

Units Affected
7,703 bottles
Distribution
Nationwide in the USA
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 7,703 bottles.
Why was this product recalled?
Failed Dissolution Specifications; during long term stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 6, 2022. Severity: Moderate. Recall number: D-0738-2022.