Reported Jun 1, 2022 · Terminated

Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC…

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 (dolutegravir) Tablets 50 mg
    • 30-count Bottle
    • Rx Only
  • Manufactured for
    • ViiV Healthcare RTP
    • NC 27709
    • NDC 49702-228-13
Lot codes and dates
  • Lot
    • 2A9E
    • Exp 1/2027
Amount recalled
328 bottles

Where it was sold

  • Nationwide

Why it was recalled

Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.

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 Aug 17, 2023 · Data as of Sep 19, 6:37 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.