Recall archive / FDA drug enforcement

Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Wa... — FDA record D-0460-2022

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 Jan 5, 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: Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
Reason: Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Classification: Class II
Recalling firm: Akorn, Inc.
Quantity: 31,510 ampules
Agency-reported status: Terminated
Source record identifier: D-0460-2022

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Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot # 031489A, Expiration 03/31/2022

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: Jan 19, 2022
Recall initiation date: Jan 5, 2022
Center classification date: Jan 27, 2022
Termination date: Sep 17, 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.