Allergen Hub

Gluten Recalls in the United States

532 food recalls involving gluten tracked from FDA open data. Updated daily.

532 Gluten Recalls

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medical Class II
2020-05-06

Bio-Rad Labs recalls Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test;

An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is largely due to samples with higher levels of antibodies. With the cut-off for the assay being 15 U/mL, the clinical classifications for most samples would remain unchanged.

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drugs Class II
2016-02-03

Perrigo Company PLC recalls Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottl

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

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drugs Class II
2016-02-03

Perrigo Company PLC recalls Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and De

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

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drugs Class I
2019-03-20

King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Grains & Gluten Into

Microbial contamination

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drugs Class I
2019-03-20

King Bio Inc. recalls Dr. King's SafeCare Rx Allergies: Grains & Gluten, 2 fl. oz.

Microbial contamination

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drugs Class I
2019-06-19

Novis PR, Inc. recalls Pecgen DMX Cough Suppressant Expectorant, Contains the same

Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.

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drugs Class II
2019-06-26

P & L Developments, LLC recalls Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, An

cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

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drugs Class II
2021-06-02

Cardinal Health Inc. recalls Prenatal Tablets Gluten Free Multivitamin/ Multimineral Diet

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

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drugs Class II
2024-12-25

Keystone Industries recalls Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Fre

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

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drugs Class II
2024-12-25

Keystone Industries recalls Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content:

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

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drugs Class II
2024-12-25

Keystone Industries recalls Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Con

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

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drugs Class II
2024-12-25

Keystone Industries recalls safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

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drugs Class II
2024-12-25

Keystone Industries recalls Quala Dental Products, Topical Anesthetic Gel, Contains 20%

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

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Food Class I
2013-07-24

Sani Fresh Distribution recalls Sani Fresh Distribution brand MINI KAISER 10, Net Weight 13

Canadian firm recalled Mini Kaiser 10 due to undeclared soy in the product. The product was also found to contain undeclared wheat, sulfites, soybean oil and gluten (barley and/or rye) all from the Doughmaster 200 raw material.

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Food Class II
2013-08-28

Pacific Pure Aid recalls Roasted Red Bell Pepper Plus Powder 50 lb carton

The product contained gluten and is sold as gluten free.

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Food Class II
2013-08-28

Pacific Pure Aid recalls Fried Onion Powder 44.092 lb carton

The product contained gluten and is sold as gluten free.

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Food Class II
2013-08-28

Pacific Pure Aid recalls Thai Chili Flake

The product contained gluten and is sold as gluten free.

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Food Class II
2013-08-28

Mariposa Baking Co. recalls Penguinos - four cream filled chocolate cupcakes: gluten, w

Mariposa Baking received a complaint from consumer who found a piece of coconut in a cupcake. Coconut is not an ingredient of the product and was not listed on the ingredient label

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Food Class III
2013-09-11

La Terra Fina USA, Inc. recalls Chunky Spinach Artichoke and Parmesan Dip: Gluten Free, Tra

One lot Spinach Artichoke & Parmesan dip contains the ingredient and nutrition information for Caramelized onion dip. Both dips have the same allergens statement - Milk, Soy and Egg.

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Food Class II
2013-11-20

Apex Energetics recalls LGS-Zyme (Z12), Enzyme-Based Multivitamin & Amino Acid Dieta

Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol.

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