Pain Aid ESF Recall: Acetaminophen/Aspirin/Caffeine Tablets
Ultratab Laboratories recalls Pain Aid ESF tablets due to CGMP deviations and failed stability results. Check lot numbers for details.
Use caution until it’s fixed
CGMP Deviations: failed stability results, inadequate laboratory investigations,
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What happened, in plain English
Ultratab Laboratories, Inc. is recalling Pain Aid ESF tablets because of Current Good Manufacturing Practice (CGMP) deviations, including failed stability results and inadequate laboratory investigations. The affected product contains Acetaminophen USP 250mg, Aspirin USP 250mg, and Caffeine 65mg. Approximately 14 bulk lots are involved in this recall. Read more at govinfonow.com/recall/35507-pain-aid-esf-recall-acetaminophen-aspirin-caffeine-tablets.
Source Summary by GovInfoNow · govinfonow.com/recall/35507-pain-aid-esf-recall-acetaminophen-aspirin-caffeine-tablets · Updated October 10, 2026 · FDA enforcement record: FDA #D-0327-2022
Cite this page
“Pain Aid ESF Recall: Acetaminophen/Aspirin/Caffeine Tablets.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35507-pain-aid-esf-recall-acetaminophen-aspirin-caffeine-tablets. Based on FDA recall #D-0327-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0327-2022%22&limit=1).
Why it’s dangerous
The hazard stems from CGMP deviations, specifically failed stability results and inadequate laboratory investigations. These issues mean the product's quality or potency may not meet specifications, though the record does not specify a direct injury mechanism like toxicity or contamination.
Who’s affected
This recall affects customers who purchased the recalled bulk lots of Pain Aid ESF tablets from Ultratab Laboratories, Inc., including any downstream distributors. Individuals taking these specific OTC pain relief tablets may be affected.
How to tell if you have this one
Look for Pain Aid ESF tablets packaged in corrugated boxes lined with 2 polyethylene bags (100 lb). Check for NDC# 62959-560-00, Product Code M560L, and one of the following Bulk Lots: 18K070, 19A046, 19C073, 19E014, 19G039, 19K002, 20A013, 20B050, 20C011, 20C049, 20F071, 20F072, 20G033, or 20G041.
- Brand
Pain Aid- Category
Drug
What to do — step by step
Check Your Product
Verify if your Pain Aid ESF tablets match the recalled NDC, Product Code, and Bulk Lots listed in the record.
Contact Manufacturer
Since the remedy is not stated in the record, contact Ultratab Laboratories, Inc. directly for instructions on returns or disposal.
How this recall unfolded
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0327-2022 (November 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0327-2022 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.