Drug Recall: Tivicay Tablets with Incorrect Expiration Date on Label
GlaxoSmithKline is recalling 328 bottles of Tivicay (dolutegravir) tablets nationwide due to incorrect expiration date labeling. The label shows January 2027 but the correct expiration date is September 2026.
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 an FDA Class III recall involving a minor labeling error where an incorrect expiration date was printed on the product label. No illnesses, injuries, or safety hazards with the product itself have been reported.
Plain-English summary
GlaxoSmithKline LLC is recalling Tivicay (dolutegravir sodium) 50 mg tablets because an incorrect expiration date was printed on the product labeling. The label displays an expiration date of January 2027, whereas the correct expiration date is September 2026.
The affected product is Lot 2A9E. A total of 328 bottles were distributed nationwide in the United States. Patients and healthcare providers who have received this product should verify the correct expiration date before dispensing or using the medication.
No illnesses or injuries related to this labeling error have been reported. Patients currently taking Tivicay from this lot should consult their healthcare provider or pharmacist if they have concerns about the expiration date on their medication.
The recalled product
- Product
- TIVICAY (DOLUTEGRAVIR SODIUM)
- Brand
- TIVICAY
- Manufacturer
- GlaxoSmithKline LLC
- Category
- Drug — HIV / Antiretroviral
- Affected units
- 328
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 (2)
- Lot: 2A9E
- Exp 1/2027
UPCs (3)
- 0349702227132
- 0349702226135
- 0349702228139
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · TIVICAY
- ModerateTIVICAY HIV medication carton mislabeled with incorrect expiration date
FDA (Drugs) · 2024-06-12
- ModerateViiv Healthcare Recalls Tivicay Tablets Due to Cross-Contamination with Promacta
FDA (Drugs) · 2014-04-09
Same manufacturer · GlaxoSmithKline LLC
See all →- ModerateAnoro Ellipta inhalation powder recalled for failed release testing defect
FDA (Drugs) · 2024-01-03
- HighGlaxoSmithKline Recalls Ventolin HFA Inhalers Due to Defective Delivery System
FDA (Drugs) · 2017-05-31
- ModerateGlaxoSmithKline Recalls Ventolin Inhalers Due to Defective Delivery System
FDA (Drugs) · 2017-04-12
- SevereGlaxoSmithKline Recalls Bactroban Nasal Ointment Due to Penicillin Contamination
FDA (Drugs) · 2016-07-27
- SevereGlaxoSmithKline Recalls Bactroban Ointment Due to Penicillin Cross-Contamination
FDA (Drugs) · 2016-07-27
Same hazard · incorrect expiration date
See all →- ModerateHiRes Ultra 3D cochlear implants carry an incorrect expiration date
FDA (Devices) · 2026-06-10
- HighIrix-A Lumbar Fusion Implants Recalled for Incorrect Expiration Dates
FDA (Devices) · 2025-02-26
- ModerateBiodesign Otologic Butterfly Graft Recall: Incorrect Instructions and Expiration Date
FDA (Devices) · 2025-01-22
- HighHAWK Advanced Hypothermia Management Set recalled for incorrect expiration dates
FDA (Devices) · 2024-09-25
- ModerateEmergency Hypothermia Management Kits Recalled for Incorrect Expiration Dates
FDA (Devices) · 2024-09-25