FDA Drug recall D-1492-2016
Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc
- FDA Drug
- Class III
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class III recall of Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc by Lupin, citing CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1492-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-02-19 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Lupin |
| Distribution | n/a |
Product
Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09
Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Identifiers
| ndc | 68180-750-09 |
|---|---|
| ndc | 68180-751-09 |
| ndc | 68180-751-03 |
| ndc | 68180-751-17 |
| ndc | 68180-752-09 |
| ndc | 68180-752-03 |
| ndc | 68180-719-03 |
| ndc | 68180-719-09 |
| ndc | 68180-720-09 |
| ndc | 68180-720-03 |
| ndc | 68180-721-03 |
| ndc | 68180-721-09 |
| ndc | 68180-233-01 |
| ndc | 68180-233-02 |
| ndc | 68180-455-02 |
| ndc | 68180-455-01 |
| code_info | Lot #: G304799, Exp. 4/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Lupin
- Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202,…
FDA Drug · Class II · 2017-11-29 · Lupin - Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by:…
FDA Drug · Class III · 2016-09-28 · Lupin - Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc
FDA Drug · Class III · 2016-09-14 · Lupin
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1492-2016%22
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