RecallRadar

FDA Drug recall D-0893-2023

ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd

On 2023-06-28 the FDA classified a Class I recall of ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd by The Harvard Drug Group, citing labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0893-2023
ClassificationClass I
Statusterminated
Initiated2023-05-31
Published2023-06-28
Last updated2026-09-13 11:52 UTC
CompanyThe Harvard Drug Group
DistributionUS

Product

ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08

Reason

Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.

Identifiers

ndc0904-6269-08
ndc0904-6269-45
ndc0904-6270-08
ndc0904-6270-45
ndc0904-6271-08
ndc0904-6271-45
ndc0904-6272-08
ndc0904-6272-45
code_infoLot: T04769 Exp. 2024/12

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-0893-2023%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.