Bacaolinita Liquid Dietary Supplement Recalled for Undeclared PEG-40 Ingredient
Procaps is recalling Bacaolinita Liquid Dietary Supplement (8 fl oz bottles) because PEG-40 was not declared on the product label. Consumers should discontinue use.
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 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: FDA Class II recall for labeling defect (undeclared ingredient). No illnesses or injuries reported. The hazard is theoretical, qualifying as a minor labeling error without demonstrated harm.
Plain-English summary
Procaps S.A. de C.V. is recalling Bacaolinita Liquid Dietary Supplement With Vitamins A and D + B12 (8 fl oz / 236 mL bottles, UPC 841548000028) due to an undeclared ingredient on the label. The ingredient PEG-40 was not listed among the labeled ingredients.
The recall affects 33,684 boxes distributed in Delaware, Texas, and California. Affected lot numbers are: 1358739, 1379697, 1379718, 1387103, 1404273, 1416127, 1420872, 1423729, and 1451962.
Consumers who have purchased this product should stop using it. No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- Bacaolinita Liquid Dietary Supplement With vitamins A and D + B12 8 fl. oz (236 mL) UPC 841548000028 packaged in a bottle inside a cardboard box
- Manufacturer
- Procaps S.A. de C.V.
- Category
- Food — Dietary Supplement
- Affected units
- 33,684
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 (9)
- Lot #: 1358739
- 1379697
- 1379718
- 1387103
- 1404273
- 1416127
- 1420872
- 1423729
- 1451962
Distribution
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