Recall archive / FDA drug enforcement

Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x ... — FDA record D-1262-2022

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 Jun 30, 2022. 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: Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
Reason: Lack of Assurance of Sterility
Classification: Class II
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 184,370 syringes
Agency-reported status: Terminated
Source record identifier: D-1262-2022

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: LB2002A, Exp. 7/12/2022; LB2004A, Exp. 8/21/2022; LB2006A, Exp. 9/3/2022; LB2008A, Exp. 10/6/2022

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

Distribution

Nationwide in the 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: Jul 27, 2022
Recall initiation date: Jun 30, 2022
Center classification date: Jul 18, 2022
Termination date: Jun 17, 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.