Reported Jun 12, 2024 · Terminated

Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60…

GlaxoSmithKline LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GlaxoSmithKline LLC · 1011 N Arendell Ave · Zebulon, NC · 27597-2309

Is this the product you have?

  • Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only
  • Mfd forViiV Healthcare Durham, NC, 27701
  • By
    • GlaxoSmithKline Durham
    • NC 27701
    • NDC 49702-255-37
Lot codes and dates
    • Lot #: AG4M
    • Labeled Expiry date on carton May 2026
    • correct Exp. Date 04/2025
Amount recalled
463 Cartons

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 29, 2025 · Data as of Sep 19, 8:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.