Recall: D-0737-2022

Class II - Potentially Harmful

Class IIClassification

2022-03-23Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

Product

Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India

Reason

Failed Dissolution Specifications; during long term stability testing.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.