Class II · ModerateRecall completed
DILOTAB II
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: AK9548, (L) 106, Exp. Date 04/2022; AK9647, (L)103, Exp. Date 06/2022; AK9598, Exp. Date 05/2022
Where it was soldNationwide within the United States
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
cGMP deviations
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 |
| NDC | 42961-052-03 |
Show the full FDA record
| Full product label | DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03 |
| Recalling firm | Ultra Seal Corporation |
| Distribution | Nationwide within the United States |
| Quantity | 2,685,700 packets |
| Recall initiated | 2022-01-24 |
| Report date | 2022-02-09 |
| Recall completed | 2023-10-16 |
| Recall number | D-0490-2022 |
| Classification | Class II |
| 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.