Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PAIN AID ESF- (Acetaminopehn USP 250mg Recalled by ULTRAtab Laboratories, Inc. Due to CGMP Deviations: failed stability results, inadequate laboratory investigations,

Date: November 29, 2021
Company: ULTRAtab Laboratories, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ULTRAtab Laboratories, Inc. directly.

Affected Products

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

Quantity: 14 bulk lots (approximately 1,987,951 tablets each)

Why Was This Recalled?

CGMP Deviations: failed stability results, inadequate laboratory investigations,

Where Was This Sold?

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

About ULTRAtab Laboratories, Inc.

ULTRAtab Laboratories, Inc. has 43 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report