# FDA recall D-0896-2022

> **GlaxoSmithKline LLC** · Class III · drug recall initiated 2022-05-13.

## Product

Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.

## 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.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-0896-2022
- **Recalling firm:** GlaxoSmithKline LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-13
- **Report date:** 2022-06-01
- **Termination date:** 2023-08-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Zebulon, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0896-2022

## Citation

> AI Analytics. FDA recall D-0896-2022. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-0896-2022. Source: US FDA. Licensed CC0.

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