D-1536-2022 Class II Terminated
FDA drug recall D-1536-2022 was initiated by Lupin Pharmaceuticals Inc. on Sep 13, 2022 and is designated Class II. Reason for recall: Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. The recall status is terminated (terminated Jan 31, 2024). Affected quantity: 11,802 1000-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 21, 2022
- Initiation Date
- Sep 13, 2022
- Termination Date
- Jan 31, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,802 1000-count bottles
Product Description
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
Reason for Recall
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Distribution Pattern
Product was distributed to major distributors/wholesalers nationwide.
Code Information
Lot # Q201182, exp. date March 2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1536-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026