TIVICAY HIV medication carton mislabeled with incorrect expiration date
GlaxoSmithKline recalls TIVICAY cartons nationwide with incorrect expiration date on packaging. The carton label shows May 2026, but the correct expiration on the bottle is April 2025.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a minor labeling error on carton packaging only, with no reported illnesses or injuries. The actual medication expiration date (April 2025) is correct on the bottle label; only the carton label is incorrect. Per FDA Class III classification and the severity rubric, this constitutes a Moderate recall.
Plain-English summary
GlaxoSmithKline LLC is recalling TIVICAY (dolutegravir sodium) 5mg Tablets for Oral Suspension nationwide. The carton packaging for affected units displays an incorrect expiration date of May 2026, while the correct expiration date shown on the tablet bottle label inside the carton is April 2025.
The recall affects 463 cartons of TIVICAY PD distributed nationwide within the United States. Each carton contains one bottle of 60 tablets, one 30-mL dosing cup, and one 10-mL oral dosing syringe. The affected lot number is AG4M.
The labeling discrepancy could lead patients to confusion about the true expiration date of their medication. Patients relying on the incorrect carton label may discard medication prematurely or continue using medication past its actual expiration date.
Patients and healthcare providers should refer to the expiration date on the tablet bottle label (April 2025), not the carton, when determining medication validity. Persons who have TIVICAY cartons with lot AG4M bearing an expiration date of May 2026 should contact their pharmacy or healthcare provider for replacement.
The recalled product
- Product
- TIVICAY (DOLUTEGRAVIR SODIUM)
- Brand
- TIVICAY
- Manufacturer
- GlaxoSmithKline LLC
- Category
- Drug — Antiretroviral
- Hazard
- mislabeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: AG4M
- Labeled Expiry date on carton May 2026
- correct Exp. Date 04/2025
UPCs (3)
- 0349702227132
- 0349702226135
- 0349702228139
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · TIVICAY
- ModerateDrug Recall: Tivicay Tablets with Incorrect Expiration Date on Label
FDA (Drugs) · 2022-06-01
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27