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
- Hazard
- incorrect-expiration-date
- mis-labeling
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.
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