DoctoRx Ocular Support Softgels Recalled for Undeclared Fish Allergen
Golden Lab LLC is recalling DoctoRx's Optimal Formula Dry Eye Formula Ocular Support Softgels because they contain undeclared fish allergen, which poses a risk to consumers with fish allergies.
The agency’s classification
FDA (Food): 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 3/5 (High).
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: The recall involves allergen mislabeling for a common allergen (fish) where the hazard is real but no illnesses or injuries are reported in the source text. This meets the High severity criterion for allergen mislabeling on common allergens.
Plain-English summary
Golden Lab LLC is recalling DoctoRx's Optimal Formula, Dry Eye Formula, Ocular Support Softgel (60 softgels per package) due to the presence of undeclared fish allergen in the product.
The affected lots are D93210669 and E11290344. A total of 13,079 units were distributed domestically.
Consumers who have a fish allergy and have purchased this product should not consume it. Anyone who has an allergic reaction should seek medical attention. Consumers should discontinue use and contact their healthcare provider or poison control if they experience an allergic reaction. The product should be returned to the place of purchase.
The recalled product
- Product
- DoctoRx's Optimal Formula, Dry Eye Formula, Ocular Support Softgel, 60 Softgels/Dietary Supplement
- Manufacturer
- Golden Lab LLC
- Affected units
- 13,079
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)
- Lots: D93210669 and E11290344
Distribution
Distribution scope not specified by the agency.
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