FDA Drug recall D-0014-2023
NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ E…
- FDA Drug
- Class III
- terminated
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class III recall of NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ E… by Lnk International, citing boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0014-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-10-11 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lnk International |
| Distribution | US |
Product
NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
Reason
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Identifiers
| ndc | 0363-6171-09 |
|---|---|
| code_info | P129910 P129911 P130240 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0014-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.