RecallRadar

FDA Drug recall D-0263-2022

Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, Ea…

On 2021-12-01 the FDA classified a Class III recall of Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, Ea… by Aurobindo Pharma Usa, citing failed Impurities/Degradation Specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0263-2022
ClassificationClass III
Statusterminated
Initiated2021-11-15
Published2021-12-01
Last updated2026-09-13 11:52 UTC
CompanyAurobindo Pharma Usa
DistributionUS

Product

Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05

Reason

Failed Impurities/Degradation Specifications

Identifiers

ndc65862-142-01
ndc65862-142-05
ndc65862-142-99
ndc65862-143-01
ndc65862-143-05
ndc65862-143-99
ndc65862-144-01
ndc65862-144-05
ndc65862-144-99
ndc65862-145-01
ndc65862-145-05
ndc65862-145-99
code_infoBatch QG0619030-A, exp 11/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0263-2022%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.