Tivicay PD — Class III drug recall D-0544-2024
Terminated recall by GlaxoSmithKline LLC, reported 2024-06-12, distributed nationwide. Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the
| Recall number | D-0544-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GlaxoSmithKline LLC, Zebulon, NC, United States |
| Recall initiated | 2024-05-17 |
| Classified | 2024-06-06 |
| Reported by FDA | 2024-06-12 |
| Terminated | 2025-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 463 cartons |
| Reason classes | labeling |
| NDC | 49702-0226, 49702-0226-13, 49702-0227, 49702-0227-13, 49702-0228, 49702-0228-13, 49702-0255, 49702-0255-37 |
| Lot numbers | AG4M |
| Expiration dates | 2025-04 |
Product
Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37
Reason for recall
Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
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-0544-2024. 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.