CLASS III Drug recall · Reported 12 Jun 2024 · FDA Enforcement Report
Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension recalled
GlaxoSmithKline is recalling Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, Each carton contains one, distributed nationwide in the US. The recall was initiated on 17 May 2024 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-0544-2024
- FDA event ID
- 94634
- Recalling firm
- GlaxoSmithKline, Zebulon, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 May 2024
- FDA classified
- 6 Jun 2024
- Reported
- 12 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 17 May 2024 | Recall initiated by company | |
| 6 Jun 2024 | Classified by FDA | +20 days |
| 12 Jun 2024 | Published in enforcement report | +6 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 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.
Product as listed by the FDA
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 for: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
Where was it sold?
Nationwide within the United States
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 9 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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