Recall archive / FDA company announcement

Major Pharmaceuticals: Dronabinol Capsules 2.5mg and Ziprasidone Hydrochloride Capsules 20mg — FDA announcement Jun 14, 2023

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jun 14, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Dronabinol Capsules 2.5mg and Ziprasidone Hydrochloride Capsules 20mg
Reason: Packaging may contain incorrect product due to labeling mix-up
Classification: Not supplied
Recalling firm: The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories
Quantity: Not supplied
Agency-reported status: Terminated in FDA listing
Source record identifier: 269b886de254c25b

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE – June 13, 2023 – La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories is initiating a voluntary recall of a single lot of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg to the consumer level. The Harvard Drug Group, LLC received a customer complaint from a distributor, that some 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 for Lot T04769. Accordingly, The Harvard Drug Group, LLC is recalling all of 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.; Both Ziprasidone Hydrochloride Capsules, 20 mg and Dronabinol Capsules, USP, 2.5 mg are labeled with lot T04769 EXP. 2024/12 and can be identified on the outer carton labeling as follows:; 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

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE – June 13, 2023 – La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories is initiating a voluntary recall of a single lot of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg to the consumer level. The Harvard Drug Group, LLC received a customer complaint from a distributor, that some 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 for Lot T04769. Accordingly, The Harvard Drug Group, LLC is recalling all of 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.; Both Ziprasidone Hydrochloride Capsules, 20 mg and Dronabinol Capsules, USP, 2.5 mg are labeled with lot T04769 EXP. 2024/12 and can be identified on the outer carton labeling as follows:; 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

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
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

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Jun 14, 2023
Company announcement date: Jun 13, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.