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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Food
Food & Beverages/Dietary Supplements

Bacaolinita Liquid Dietary Supplement Recalled for Undeclared Ingredient

Agency Publication Date: June 7, 2023
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Summary

Procaps S.A. de C.V. has recalled 33,684 boxes of Bacaolinita Liquid Dietary Supplement because the ingredient PEG-40 was not declared on the product label. The recalled product contains vitamins A, D, and B12 and is packaged in 8-fluid-ounce (236 mL) bottles inside a cardboard box. This voluntary recall was initiated after it was discovered that the ingredient was omitted from the labeling. No illnesses or injuries have been reported to date.

Risk

The product contains PEG-40 (hydrogenated castor oil), an ingredient not listed on the label, which could pose health risks to individuals who are sensitive or allergic to this compound. No injuries or incidents have been reported in connection with this recall.

What You Should Do

  1. This recall affects 8 fl. oz (236 mL) bottles of Bacaolinita Liquid Dietary Supplement with UPC 841548000028. The product contains vitamins A and D + B12 and is packaged in a bottle inside a cardboard box.
  2. Check the packaging for the following lot numbers: 1358739, 1379697, 1379718, 1387103, 1404273, 1416127, 1420872, 1423729, and 1451962.
  3. Stop using the recalled product immediately.
  4. Return the product to the place of purchase for a full refund, throw it away, or contact Procaps S.A. de C.V. for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report an adverse event.

Your Remedy Options

You have 2 options:

💰Option 1: Full Refund
How to: Return the product to the place of purchase for a full refund, or contact the manufacturer or supplier for further instructions
🗑️Option 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: Bacaolinita Liquid Dietary Supplement With vitamins A and D + B12 (8 fl. oz / 236 mL)
UPC Codes:
841548000028
Lot Numbers:
1358739
1379697
1379718
1387103
1404273
1416127
1420872
1423729
1451962

Packaged in a bottle inside a cardboard box.

Product Images

Box of Bacaolinita liquid dietary supplement

Box of Bacaolinita liquid dietary supplement

Label for Bacaolinita liquid dietary supplement

Label for Bacaolinita liquid dietary supplement

Caja de suplemento dietético líquido Bacaolinita

Caja de suplemento dietético líquido Bacaolinita

Etiqueta del suplemento dietético líquido Bacaolinita

Etiqueta del suplemento dietético líquido Bacaolinita

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92385
Status: Resolved
Manufacturer: Procaps S.A. de C.V.
Manufactured In: El Salvador
Units Affected: 33,684 Boxes
Distributed To: Delaware, Texas, California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release (1) · FDA Press Release (2) · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.