Recall archive / FDA drug enforcement

PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugat... — FDA record D-0327-2022

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 Nov 29, 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: PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L
Reason: CGMP Deviations: failed stability results, inadequate laboratory investigations,
Classification: Class II
Recalling firm: ULTRAtab Laboratories, Inc.
Quantity: 14 bulk lots (approximately 1,987,951 tablets each)
Agency-reported status: Terminated
Source record identifier: D-0327-2022

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	Bulk Lots: 18K070, exp. date Nov-21; 19A046, exp. date Jan-22; 19C073, exp. date Mar-22; 19E014, exp. date May-22; 19G039, exp. date Jul-22; 19K002, exp. date Nov-22; 20A013, exp. date Jan-23; 20B050, exp. date Feb-23; 20C011, exp. date Mar-23; 20C049, exp. date Mar-23; 20F071, exp. date Jun-23; 20F072, exp. date Jun-23; 20G033, exp. date Jul-23; 20G041, exp. date Jul-23.

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

Distribution

Product was distributed to one customer who may have further distributed the product.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Jan 12, 2022
Recall initiation date: Nov 29, 2021
Center classification date: Jan 4, 2022
Termination date: Feb 24, 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.