Recall archive / FDA drug enforcement

Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive ... — FDA record D-0771-2023

Reported ongoing

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 May 11, 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: Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.
Reason: Sub-potent Drug
Classification: Class II
Recalling firm: Revive Rx LLC dba Revive Rx Pharmacy
Quantity: 45 Vials
Agency-reported status: Ongoing
Source record identifier: D-0771-2023

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	Lot: 1643397 BUD: 10/16/2023

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

Distribution

Nationwide in the US

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: May 31, 2023
Recall initiation date: May 11, 2023
Center classification date: May 25, 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.