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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 PD Tablets Recalled for Incorrect Expiration Date Labeling

Agency Publication Date: June 6, 2024
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Summary

GlaxoSmithKline LLC has recalled 463 cartons of Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, a medication used to treat HIV. The recall was initiated because the outer cartons were printed with an incorrect expiration date of May 2026, whereas the actual expiration date of the medication is April 2025. While the date on the individual tablet bottle inside is correct, the error on the outer carton could lead patients to use the medicine after it has expired.

Risk

Using medication past its true expiration date may result in the drug being less effective at treating the underlying condition. If a patient continues to use this medication between May 2025 and May 2026 based on the incorrect carton label, they would be taking expired medicine.

What You Should Do

  1. This recall affects Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension packaged in 60-count cartons (NDC 49702-255-37) with lot number AG4M.
  2. Check the expiration date printed on the outer carton; affected units incorrectly show an expiration of May 2026, while the bottle label inside correctly shows April 2025.
  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 GlaxoSmithKline LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have 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 PD (dolutegravir) 5mg Tablets for Oral Suspension (60-count bottle)
Variants: 5mg, 60-count bottles, Oral Suspension
Lot Numbers:
AG4M (Labeled Exp May 2026; Correct Exp 04/2025)
NDC:
49702-255-37

Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94634
Status: Resolved
Manufacturer: GlaxoSmithKline LLC
Manufactured In: United States
Units Affected: 463 Cartons
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.