Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension recall
FDA recall D-0544-2024 · initiated May 17, 2024
GlaxoSmithKline LLC recalled Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension in May 2024 — an FDA Class III recall (D-0544-2024) because 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.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
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.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 463 Cartons
Details
- Product
- Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37
- Recalling company
- Glaxosmithkline LLC
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- May 17, 2024
- FDA report date
- Jun 12, 2024
This recall is linked to a product we cover: Tivicay →
Frequently asked
- Was Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension recalled?
- GlaxoSmithKline LLC recalled Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension in May 2024 — an FDA Class III recall (D-0544-2024) because 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0544-2024 was: 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 a recalled Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0544-2024.