The Harvard Drug Group, LLC, Issues Voluntary Nationwide Recall of Dronabinol Capsules, USP, 2.5 mg, and Ziprasidone Hydrochloride Capsules, 20 mg, Because of Label Mix-Up

The Harvard Drug Group, LLC, is recalling all of the affected lot T04769, dronabinol capsules, USP, 2.5 mg, which may be in outer cartons that read dronabinol capsules, USP, 2.5 mg, or ziprasidone hydrochloride capsules, 20 mg.

To date, the Harvard Drug Group, LLC, has not reported any adverse events related to the recall.

Patients who take dronabinol capsules, USP, 2.5 mg, instead of ziprasidone hydrochloride capsules, 20 mg, can experience serious adverse events from missing their ziprasidone dose and taking an unexpected dose of dronabinol. Patients missing doses of ziprasidone can experience exacerbations of underlying health issues such as bipolar disorder, schizophrenia, agitation, aggression, or delirium that can result in mental illness instability with possible consequences of self-harm or harm to others, which could result in medical or psychiatric hospitalization. Taking an unexpected dose of dronabinol may cause mental and cognitive effects that result in mental or physical impairment, including aggravated symptoms in patients with mental illness disorders and limited ability to safely complete hazardous activities (e.g., driving a motor vehicle, operating machinery). Older adult patients or those taking other medications that affect mental function may be particularly at risk for these reactions. 

Both ziprasidone hydrochloride capsules, 20 mg, and dronabinol capsules, USP, 2.5 mg, can be identified by the following outer carton labeling:

Product Name	Package Description	Brand Name	Lot Number	NDC	Expiration Date
Dronabinol capsules, USP, 2.5 mg	100 unit doses per carton  (10 x 10 blister packs)	Major	T04769	0904-7144-61	2024/12
Ziprasidone hydrochloride capsules, 20 mg	40 unit doses per carton  (10 x 4 blister packs)	Major	T04769	0904-6269-08	2024/12

The recalled products were distributed in the United States starting in April 2023.

The Harvard Drug Group, LLC, is notifying all affected direct accounts of the voluntary recall via mail and is arranging for the return of all recalled products. Wholesalers, distributors, and retailers that have the affected product should stop distribution. Consumers should stop using the recalled product, return it to the place of purchase, and contact their healthcare provider.

Consumers with questions regarding this recall can contact Sedgwick, Inc., the claims management service, at 888-759-6904, Monday–Friday, from 8 am–5 pm EST, or at harvarddrug6068@sedgwick.com. Consumers should contact their healthcare provider if they experience any problems that may be related to taking or using the recalled products.

Healthcare professionals and consumers should report any adverse reactions or quality problems they experience using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.