Recall archive / FDA drug enforcement

Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, M... — FDA record D-0096-2023

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 27, 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: Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
Reason: Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Classification: Class III
Recalling firm: Jubilant Cadista Pharmaceuticals, Inc.
Quantity: 14,061 bottles
Agency-reported status: Terminated
Source record identifier: D-0096-2023

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#: 21P0336, Exp: 04/2023

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 11, 2023
Recall initiation date: Dec 27, 2022
Center classification date: Jan 5, 2023
Termination date: Dec 5, 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.