Recall archive / FDA drug enforcement

Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech ... — FDA record D-0368-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 3, 2021. 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: Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34
Reason: Labeling: Missing Label
Classification: Class III
Recalling firm: Akorn, Inc.
Quantity: 8184 bottles
Agency-reported status: Terminated
Source record identifier: D-0368-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lots: 377186 Exp. 2/28/2023; 377188 Exp. 3/31/2023

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

Distribution

Nationwide USA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jan 19, 2022
Recall initiation date: Dec 3, 2021
Center classification date: Jan 13, 2022
Termination date: Aug 19, 2022

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.