FDA Drug recall D-1466-2016
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-coun…
- FDA Drug
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-coun… by Mylan Institutional D B A Udl Laboratories, citing CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1466-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-17 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional D B A Udl Laboratories |
| Distribution | US |
Product
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
Reason
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Identifiers
| code_info | Lot #: a) 3039792, Exp 04/14; 3037880, Exp 01/14; 3043938, Exp 07/14; b) 3036811, Exp 10/13; 3037514, Exp 01/14; 3039975, Exp 04/14; 3042583, Exp 07/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class II · 2022-05-18 · Mylan Institutional D B A Udl Laboratories - Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carto…
FDA Drug · Class II · 2022-05-18 · Mylan Institutional D B A Udl Laboratories - Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 5…
FDA Drug · Class II · 2019-03-27 · Mylan Institutional D B A Udl Laboratories - Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by:…
FDA Drug · Class III · 2018-08-29 · Mylan Institutional D B A Udl Laboratories - Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc
FDA Drug · Class II · 2018-05-30 · Mylan Institutional D B A Udl Laboratories
All Mylan Institutional D B A Udl Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1466-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.