Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg… — Class II drug recall D-1065-2020
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-1065-2020 |
|---|---|
| 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 | 471,024 blisters |
| Reason classes | labeling |
| NDC | 00573-0196, 00573-0196-01, 00573-0196-02, 00573-0196-10, 00573-0196-20, 00573-2161, 00573-2161-03 |
| Lot numbers | 9324HA, 9327HA, R53915, R73995 |
| Model numbers | F00573019610C, F00573019610R, F00573019620C |
| Expiration dates | 2020-05-31, 2021-07-31 |
Product
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister
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-1065-2020. 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.