FDA drug recalls · openFDA

Is DOLUTEGRAVIR SODIUM recalled?

The FDA has recorded 1 recall of DOLUTEGRAVIR SODIUM (2024) , recalled under brand like TIVICAY.

Class I (most serious)

Class II

Class III

ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of DOLUTEGRAVIR SODIUM ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct ex 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 table Class III Terminated

GlaxoSmithKline LLC 2024-05-17 lots: Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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