RecallRadar

FDA Drug recall D-0494-2023

Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00

On 2023-04-12 the FDA classified a Class II recall of Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00 by Remedyrepack, citing cGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0494-2023
ClassificationClass II
Statusterminated
Initiated2023-03-20
Published2023-04-12
Last updated2026-09-13 11:52 UTC
CompanyRemedyrepack
DistributionUS

Product

Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.

Reason

cGMP Deviations

Identifiers

code_infoLot #: B1789178-080122, Exp. Date 07/31/2023; B1675475-050522, Exp. Date 05/31/2023

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-0494-2023%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.