Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8… — Class II drug recall D-1068-2020
Terminated recall by Glaxosmithkline Consumer Healthcare Holdings, reported 2020-04-01, distributed nationwide. Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the
| Recall number | D-1068-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glaxosmithkline Consumer Healthcare Holdings, Warren, NJ, United States |
| Recall initiated | 2020-03-16 |
| Classified | 2020-03-26 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2021-10-28 |
| Distributed | Nationwide (US) |
| Quantity | 566 blister |
| Reason classes | labeling |
| NDC | 00573-2161-14 |
| Lot numbers | 0017DA, 0045DB, 9327VB, 9353WA, R73995 |
| Expiration dates | 2021-07-31 |
Product
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA
Reason for recall
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
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-1068-2020. 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.