CLASS III Drug recall · Reported 1 Jun 2022 · FDA Enforcement Report
Tivicay (dolutegravir) Tablets 50 mg recalled by GlaxoSmithKline
GlaxoSmithKline is recalling Tivicay (dolutegravir) Tablets 50 mg, distributed nationwide in the US. The recall was initiated on 13 May 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0896-2022
- FDA event ID
- 90166
- Recalling firm
- GlaxoSmithKline, Zebulon, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 May 2022
- FDA classified
- 25 May 2022
- Reported
- 1 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 13 May 2022 | Recall initiated by company | |
| 25 May 2022 | Classified by FDA | +12 days |
| 1 Jun 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot: 2A9E, Exp 1/2027
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 8 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from GlaxoSmithKline
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|---|---|---|---|---|---|
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Other Tivicay (dolutegravir recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tivicay (dolutegravir) Tablets 50 mg recalled by Viiv Healthcare | Viiv Healthcare | Other | Nationwide |