Food, drugs, devices › GlaxoSmithKline LLC
Drug recall: Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 497
FDA enforcement event 90166 is a drug recall by GlaxoSmithKline LLC of Zebulon, NC, initiated 13 May 2022 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 18% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 17 Aug 2023. Initiation: voluntary: firm initiated. GlaxoSmithKline LLC has 13 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GlaxoSmithKline LLC, Zebulon, NC.
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."
Distribution
"Nationwide in the U.S."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0896-2022 | Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13. | 328 bottles | Class III | Terminated | 1 Jun 2022 |
Context
Other enforcement events for GlaxoSmithKline LLC
All 13 events for GlaxoSmithKline LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the U.S."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Aug 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.