Class III · Low risk
Tivicay PD
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.
Is Dolutegravir recalled?
Not under an active recall.
Dolutegravir was recalled 4 times in the past — all now closed. Most recent: May 17, 2024.
Most common reason: Labeling / mix-up (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dolutegravir. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Dolutegravir recalls on record
none so far in 2026; 4 on record, newest first
Class III · Low risk
Tivicay (dolutegravir)
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.
Class II · Moderate risk
Triumeq (abacavir, dolutegravir, and lamivudine)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Tivicay (dolutegravir)
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
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