Tivicay — Class III drug recall D-0896-2022
Terminated recall by GlaxoSmithKline LLC, reported 2022-06-01, distributed nationwide. Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the pro
| Recall number | D-0896-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GlaxoSmithKline LLC, Zebulon, NC, United States |
| Recall initiated | 2022-05-13 |
| Classified | 2022-05-25 |
| Reported by FDA | 2022-06-01 |
| Terminated | 2023-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 328 bottles |
| 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 | 2A9E |
| Expiration dates | 2027-01 |
Product
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
Reason for recall
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
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-0896-2022. 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.