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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Tivicay (dolutegravir) Tablets Recalled for Incorrect Expiration Date

Agency Publication Date: May 25, 2022
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Summary

GlaxoSmithKline LLC is voluntarily recalling 328 bottles of Tivicay (dolutegravir) 50 mg Tablets because the bottles were printed with an incorrect expiration date. The label displays an expiration date of January 2027, but the medication actually expires in September 2026. No injuries or incidents have been reported in connection with this labeling error.

Risk

Using medication past its actual expiration date may lead to reduced drug effectiveness. Consumers relying on the incorrect January 2027 date might unknowingly use the product after it has lost its potency in late 2026.

What You Should Do

  1. The recalled product is Tivicay (dolutegravir) 50 mg Tablets, sold in 30-count bottles under NDC 49702-228-13, specifically involving Lot 2A9E with a printed expiration date of 1/2027.
  2. To identify if your medication is affected, check the bottle label for Lot 2A9E and an expiration date listed as January 2027 (1/2027).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tivicay (dolutegravir) Tablets (50 mg, 30-count Bottle)
Variants: 50 mg, 30-count Bottle, Tablet
Lot Numbers:
2A9E (Exp 1/2027)
NDC:
49702-228-13

The label incorrectly displays an expiration date of January 2027; the correct expiration date is September 2026.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90166
Status: Resolved
Manufacturer: GlaxoSmithKline LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 328 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.