Class III · Lower riskRecall completed
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 m
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: AK-9457, exp. date 22-Jan; AK-9521, exp. date 22-Mar; AK-9959, exp. date 22-Dec; AK-1017, exp. date 23-Jan
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Ultra Seal Corporation |
Show the full FDA record
| Full product label | Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label) |
| Recalling firm | Ultra Seal Corporation |
| Distribution | Nationwide in the USA. |
| Quantity | 991,310 tablets |
| Recall initiated | 2021-10-13 |
| Report date | 2021-11-03 |
| Recall completed | 2022-03-28 |
| Recall number | D-0075-2022 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | New Paltz NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.