Bacaolinita dietary supplement recall: Reason, affected lot codes, refund, and other details revealed

Procaps S.A. DE C.V. has issued a nationwide recall for Laboratorios Lopez's Bacaolinita dietary supplement as the label of the product does not declare the presence of PEG-40 hydrogenated castor oil. It is feared that when consumed by people with sensitivity, PEG-40 hydrogenated castor oil may cause hypersensitivity reactions.

Announced on June 7, 2023, the nationwide recall applies to at least nine lots of dietary supplements. It is to be noted that PEG-40 hydrogenated castor oil is an inactive ingredient in the recalled dietary supplement and may cause severe or life-threatening reactions including anaphylaxis.

The recalled Laboratorios Lopez's Bacaolinita dietary supplement contains PEG-40 hydrogenated castor oil which may cause hypersensitivity reactions (Image via Food and Drug Administration)

While the recalled dietary supplement has not been linked with any adverse reactions or fatalities as of now, Procaps S.A. DE C.V. is urging all consumers strictly not to consume the product. The recalled product can either be disposed of safely in a closed bin or returned to the store of purchase for a full refund.

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All you need to know about Laboratorios Lopez's Bacaolinita dietary supplement recall

As per the recall notice issued on the United States Food and Drug Administration (FDA) website, the voluntary recall affects at least nine lots of Laboratorios Lopez's Bacaolinita dietary supplement produced by Procaps S.A. DE C.V. of San Salvador, El Salvador.

The recalled dietary supplement that has PEG-40 hydrogenated castor oil as one of the inactive ingredients may cause hypersensitivity reactions in people with a sensitivity. While there is not enough data regarding the effects of oral ingestion of PEG-40 hydrogenated castor oil, published reports indicate that PEG-40 can trigger severe reactions like anaphylaxis when it interacts with other medications in the patient's body.

According to the recall notice issued by the FDA, the recalled Laboratorios Lopez's Bacaolinita dietary supplement products were packed in dark amber plastic bottles of 8 Fl Oz, which were further packed in a cardboard box. Distributed throughout the regions of Texas, Delaware, California, and Rhode Island, the recalled product was sold to consumers through major retailers and online stores.

Labeled as "Bacaolinita® LIQUID• DIETARY SUPPLEMENT with Vitamins A and D + B12," the recalled product carries the UPC8-4152-0002-8. Select lots of the product affected by the voluntary recall include 1451962 (EXP: 2/15/25), 1423729 (EXP: 8/15 /24), 1420872 (EXP: 7/26/24), 1416127 (EXP: 6/27/24), 1404273 (EXP: 4/19/24), 1397103 (EXP: 3/6/24), 1379718 (EXP: 11/22/23), 1379697 (EXP: 11/22/23), and 1358739 (EXP: 7/14/2023).

The recalled Bacaolinita dietary supplement product was sold in Delaware, Texas, Rhode Island, and California (Image via FDA)

Consumers who may have bought any of the aforementioned products are urged not to consume them. The recalled dietary supplement products can either be discarded safely in a closed bin or returned to the place of purchase for a full refund. It is to be noted that recalled goods can be returned irrespective of a receipt or proof of purchase.

Individuals with doubts and queries about the recall can get in touch with the recall administrator at 1-561-444-8188. The administrator can be reached between Monday and Friday from 8:30 am to 5:00 pm EST. You can also submit your queries through an email sent to [email protected].