Ultra Seal Extra Strength Unaspirin Recall: Cgmp Deviations in 2-Caplet Packets

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Recalling firmUltra Seal Corporation521 Main St, N/A · New Paltz, NY 12561-1609

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Ultra Seal Corporation is recalling Extra Strength Unaspirin (acetaminophen 500 mg) 2-caplet packets that were distributed by ZEE Medical Distributors. The recall is due to cGMP deviations, which means the product may not meet quality standards. This could affect safety, though the specific risk isn't detailed in the notice.

Why it’s dangerous

The product was made under cGMP (current Good Manufacturing Practice) deviations, which are quality control issues that could affect safety. However, the recall notice does not specify what the exact risk is or how it might harm users.

Who’s affected

People who purchased the Extra Strength Unaspirin 2-caplet packets from ZEE Medical Distributors in Mason, Ohio, between the specified lot dates. Those with the product are most at risk.

How to tell if you have this one

Check for the product name 'Extra Strength Unaspirin (acetaminophen 500 mg) 2 Caplet packets' with the distributor ZEE Medical Distributors, LLC in Mason, Ohio. Look for lot numbers AK9599 (expiring May 2022) or AK9648 (expiring June 2022).

Brand
Ultra Seal
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the lot number and expiration date on the packaging to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Is there a remedy for this product?

The official recall notice does not specify any remedy.

What is the specific hazard with this product?

The product was made under cGMP deviations, but the exact risk is not detailed in the notice.

How can I tell if I have the recalled product?

Check for the product name 'Extra Strength Unaspirin (acetaminophen 500 mg) 2 Caplet packets' with lot numbers AK9599 (expiring May 2022) or AK9648 (expiring June 2022).

Take action

Contact Ultra Seal

We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0491-2022 — Ultra Seal Ultra Seal

Hello,

I own a Ultra Seal that is covered by recall D-0491-2022 from Ultra Seal.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-0491-2022 (January 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0491-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.

Ultra Seal Corporation recalls EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH

Recall notice