Recall archive / FDA drug enforcement

HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Lab... — FDA record D-0538-2022

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 26, 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: HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
Reason: CGMP Deviations
Classification: Class II
Recalling firm: ULTRAtab Laboratories, Inc.
Quantity: 50,585,623 tablets
Agency-reported status: Terminated
Source record identifier: D-0538-2022

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	Product Codes: L242SRC Bulk Lot: 18K086, 18L009, 18L050, 18L083, 18M025, 18M073, 18M098, 19A010, 19A084, 19A105, 19A107; Product Code: L242L Bulk Lot: 19H014; Product Code: L242PA Bulk Lot: 18F072, 18L119, 19A067, 19G043; Product Code: L242N Bulk Lot: 19H040

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

Distribution

Bulk product was distributed to 3 distributors who may have distributed finished product.

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

Dates in the source

Report date: Feb 16, 2022
Recall initiation date: Jan 26, 2022
Center classification date: Feb 9, 2022
Termination date: Jan 7, 2025

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.