Advil products recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Advil products over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record cites insanitary conditions with rodent activity affecting distributed product, and no illnesses are reported.
Plain-English summary
Advil, covering Ibuprofen Dispenser Pack with 2 tablet packets in a box containing 50 individual packets under UPC 305730154895, and Advil PM Ibuprofen Dispenser Pack with 2 caplet packets in a box containing 50 packets under UPC 305730164559, distributed by Gold Star Distribution Inc, is being recalled.
The reason given in the enforcement record is CGMP deviations: insanitary conditions including rodent exposure and activity in the firm's distribution center.
The recall covers all lots within expiry distributed by Gold Star Distribution. The record's quantity field reads 'Unkown'. Distribution was nationwide in the US. The FDA has classified the action as Class II.
Consumers who have this product should not use it and should follow the retailer's return instructions.
The recalled product
- Product
- SMV BodyTrack, System, Tomography, Computed, Emission
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Category
- Drug — Analgesic
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI/DI Not applicable: All serial numbers in distribution
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
See all →- HighPET scanners recalled over a streaking artifact in clinical images
FDA (Devices) · 2026-01-28
- HighMotrin dispensers recalled over insanitary conditions at a distribution center
FDA (Devices) · 2026-01-21
- HighSMV DSI nuclear medicine systems recalled over a potential detector fall
FDA (Devices) · 2026-01-21
- HighSMV DSX New Line systems recalled over a potential detector fall
FDA (Devices) · 2026-01-21
- HighMaxicam gamma cameras recalled over risk of detector falling from mount
FDA (Devices) · 2025-10-29
Same hazard · insanitary conditions
See all →- ModerateValley Springs Bottled Water Recalled Due to Insanitary Bottling Conditions
FDA (Food) · 2026-03-04
- ModerateValley Springs Bottled Water Recalled Due to Insanitary Bottling Conditions
FDA (Food) · 2026-03-04
- ModerateValley Springs Steamed Distilled Water Recalled Due to Insanitary Bottling Conditions
FDA (Food) · 2026-03-04
- HighFeminine hygiene products recalled over rodent activity in a distribution center
FDA (Devices) · 2026-02-04
- HighBandages and first aid kits recalled over rodent activity in storage
FDA (Devices) · 2026-02-04