Recall archive / FDA company announcement

Zendedi: dextroamphetamine sulfate tablets, 30 mg — FDA announcement Jan 25, 2024

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 Jan 25, 2024. 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: dextroamphetamine sulfate tablets, 30 mg
Reason: Mislabeled package
Classification: Not supplied
Recalling firm: Azurity Pharmaceuticals, Inc.
Quantity: Not supplied
Agency-reported status: Terminated in FDA listing
Source record identifier: 9e3b75f480838189

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE – January 24, 2024 – Woburn, Massachusetts, Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 mg tablets and found tablets of Carbinoxamine Maleate, an antihistamine drug. Upon learning of the incident, the manufacturer opened a product complaint and an investigation followed.; Product \| NDC No. \| Lot No. \| Exp. Date \| Ship Dates to Wholesalers; Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg \| 24338-856-03 \| F230169A \| 2025-06 \| 08/23/2023 – 11/29/2023

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE – January 24, 2024 – Woburn, Massachusetts, Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 mg tablets and found tablets of Carbinoxamine Maleate, an antihistamine drug. Upon learning of the incident, the manufacturer opened a product complaint and an investigation followed.; Product | NDC No. | Lot No. | Exp. Date | Ship Dates to Wholesalers; Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg | 24338-856-03 | F230169A | 2025-06 | 08/23/2023 – 11/29/2023

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	NDC No.	Lot No.	Exp. Date	Ship Dates to Wholesalers
Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg	24338-856-03	F230169A	2025-06	08/23/2023 – 11/29/2023

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: Jan 25, 2024
Company announcement date: Jan 24, 2024

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.