RecallRadar

FDA Drug recall D-1218-2015

Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11)

On 2015-07-15 the FDA classified a Class II recall of Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11) by American Health Packaging, citing CGMP Deviations: Firm did not adequately investigate customer complaints.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1218-2015
ClassificationClass II
Statusterminated
Initiated2015-06-01
Published2015-07-15
Last updated2026-09-13 11:51 UTC
CompanyAmerican Health Packaging
DistributionUS

Product

Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Reason

CGMP Deviations: Firm did not adequately investigate customer complaints.

Identifiers

code_infoLot #: 131924, Exp 07/31/2015

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-1218-2015%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.