RecallRadar

FDA Drug recall D-1504-2016

Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-2…

On 2016-09-28 the FDA classified a Class III recall of Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-2… by Sun Pharmaceutical Industries, citing failed Impurities/Degradation Specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1504-2016
ClassificationClass III
Statusterminated
Initiated2016-06-27
Published2016-09-28
Last updated2026-09-13 11:51 UTC
CompanySun Pharmaceutical Industries
DistributionUS

Product

Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512

Reason

Failed Impurities/Degradation Specifications

Identifiers

code_infoLot #: AVF0246/A, AVF0247/B, AVF0246/B, AVF0246/C; Exp. 02/17

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-1504-2016%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.