Bausch & Lomb Recalls Biotrue Multi-Purpose Contact Lens Solution
Bausch & Lomb is recalling Biotrue Multi-Purpose Contact Lens Solution due to out-of-specification results for a disinfectant.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bausch & Lomb Inc is recalling 256,440 bottles of Biotrue Multi-Purpose Contact Lens Solution, 10 fl. oz., Sterile. The recall is being conducted because of out-of-specification results for one of the two disinfectants used in the product.
The affected product was distributed nationwide in the United States. Specific lots involved in the recall include GK2127 (twin packs, SKU: 623588), GK2131 (twin packs, SKU: 623500), STL2019, and 6-pack shelf displays containing these lots (SKU: 629743).
Consumers should stop using the product and check their lot numbers against the list provided by the manufacturer. The source text does not specify further consumer instructions or report any illnesses or injuries associated with the recall.
The recalled product
- Product
- Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
- Manufacturer
- Bausch & Lomb Inc- Greenville Solutions Plant
- Hazard
- Affected units
- 256,440
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 (8)
- Lot GK2127 (twin packs)
- SKU: 623588
- GK2131 (twin packs)
- SKU: 623500
- STL2019
- (6 pk shelf display containing GK2131
- SKU: 629743 and STL2025 (6 pk shelf display containing GK2127)
- SKU: 629743.
Distribution
Distributed nationwide across the United States.
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