D-0737-2022 Class II Terminated
FDA drug recall D-0737-2022 was initiated by Dr. Reddy's Laboratories, Inc. on Mar 23, 2022 and is designated Class II. Reason for recall: Failed Dissolution Specifications; during long term stability testing. The recall status is terminated (terminated Feb 2, 2024). Affected quantity: 8,352 bottles (30-count), 1,368 bottles (90-count).
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 6, 2022
- Initiation Date
- Mar 23, 2022
- Termination Date
- Feb 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,352 bottles (30-count), 1,368 bottles (90-count)
Product Description
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 for Recall
Failed Dissolution Specifications; during long term stability testing.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0737-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026