Headache & Congestion Sinus Relief — Class II drug recall D-0484-2022
Terminated recall by Ultra Seal Corporation, reported 2022-02-09, distributed nationwide. cGMP deviations
| Recall number | D-0484-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultra Seal Corporation, New Paltz, NY, United States |
| Recall initiated | 2022-01-24 |
| Classified | 2022-01-31 |
| Reported by FDA | 2022-02-09 |
| Terminated | 2023-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 5,741,384 packets |
| Reason classes | cgmp |
| NDC | 42961-0206-02 |
| Lot numbers | 9445, AK9445, AK9515, AK9658, AK9708, K9445, K9486, K9810 |
| Expiration dates | 2022-01, 2022-02, 2022-03, 2022-06, 2022-07, 2022-09 |
Product
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02
Reason for recall
cGMP deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0484-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.