Ibuprofen 50 mg per 1 — Class II drug recall D-1067-2020
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-1067-2020 |
|---|---|
| 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 | 151,056 bottles |
| Reason classes | labeling |
| NDC | 00573-0191, 00573-0191-20, 00573-0191-22, 00573-0191-50, 00573-0191-75 |
| Lot numbers | R73761 |
| Model numbers | 0.75, 9335UA, 9336UA, F00573019150, F00573019175, F00573019175A, R56290, R60959, R74936, R78826 |
| Expiration dates | 2020-03-31, 2021-01-31, 2021-02-28, 2021-11-30 |
Product
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)
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-1067-2020. 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.