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.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1466-2016%22

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