RecallRadar

FDA Drug recall D-1273-2019

Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceu…

On 2019-05-15 the FDA classified a Class II recall of Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceu… by Zydus Pharmaceuticals Usa, citing labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1273-2019
ClassificationClass II
Statusterminated
Initiated2019-04-25
Published2019-05-15
Last updated2026-09-13 11:52 UTC
CompanyZydus Pharmaceuticals Usa
DistributionUS

Product

Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05

Reason

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

Identifiers

ndc68382-092-17
ndc68382-092-01
ndc68382-092-05
ndc68382-093-17
ndc68382-093-05
ndc68382-093-01
ndc68382-094-17
ndc68382-094-01
ndc68382-094-05
ndc68382-095-17
ndc68382-095-01
ndc68382-095-05
code_infoZ804517, exp Nov 30, 2020

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-1273-2019%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.