FDA Drug recall D-0896-2022
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13
- FDA Drug
- Class III
- terminated
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class III recall of Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13 by Glaxosmithkline, citing 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 co….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0896-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-05-13 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glaxosmithkline |
| Distribution | US |
Product
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
Reason
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.
Identifiers
| ndc | 49702-255-37 |
|---|---|
| ndc | 49702-226-13 |
| ndc | 49702-227-13 |
| ndc | 49702-228-13 |
| code_info | Lot: 2A9E, Exp 1/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0896-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.