FDA Recall
Terminated
Historical recordClass II
Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5.
by POLARIZED LLC
- Reason
- CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC 612520481094
by WORLD EVENT PROMOTIONS, LLC
- Reason
- Subpotent Drug: Product was found to be subpotent. Product also has high pH levels
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005
by Allergan PLC
- Reason
- SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02
by Allergan PLC
- Reason
- SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5.
by UVT INC
- Reason
- Chemical Contamination: Product contains undeclared methanol.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BUILT BRANDS LLC
- Product
- Toffee Almond Chocolate covered protein bars, packaged in me…
- Reason
- Products may be moldy prior to the end of the stated shelf life.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BUILT BRANDS LLC
- Product
- Black Cherry Chocolate Creme Chocolate covered protein bars,…
- Reason
- Products may be moldy prior to the end of the stated shelf life.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BUILT BRANDS LLC
- Product
- S'Mores Chocolate covered protein bars, packaged in metalize…
- Reason
- Products may be moldy prior to the end of the stated shelf life.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BUILT BRANDS LLC
- Product
- Peanut Butter Chocolate covered protein bars, packaged in me…
- Reason
- Products may be moldy prior to the end of the stated shelf life.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BUILT BRANDS LLC
- Product
- Double Chocolate Mousse Chocolate covered protein bars, pack…
- Reason
- Products may be moldy prior to the end of the stated shelf life.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BUILT BRANDS LLC
- Product
- Cookie Dough Chocolate covered protein bars, packaged in met…
- Reason
- Products may be moldy prior to the end of the stated shelf life.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BUILT BRANDS LLC
- Product
- Cashew Caramel with Coconut Chocolate covered protein bars,…
- Reason
- Products may be moldy prior to the end of the stated shelf life.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BUILT BRANDS LLC
- Product
- Banana Chocolate Creme Chocolate covered protein bars, packa…
- Reason
- Products may be moldy prior to the end of the stated shelf life.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BUILT BRANDS LLC
- Product
- Banana Nut Bread Chocolate covered protein bars, packaged in…
- Reason
- Products may be moldy prior to the end of the stated shelf life.
- Published
- August 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub, Non-sterile Solution, Extra strength Formula*, 8.45 fl. oz. (250 ml) bottle, Labeled with green or blue labels, Manufactured by Mystic Intl S.A. de C.V. UPC barcode: 7 87790 33952 6
by Transliquid Technologies, LLC
- Reason
- Chemical Contamination: Presence of Undeclared Methanol
- Published
- July 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
by Lupin Pharmaceuticals Inc.
- Reason
- Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
- Published
- July 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10
by Fresenius Kabi USA, LLC
- Reason
- Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
- Published
- July 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals, Inc., The Physicians Solutions.
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
- Published
- July 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.
by Keryx Biopharmaceuticals, Inc.
- Reason
- cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
- Published
- July 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
by Akorn, Inc.
- Reason
- Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
- Published
- July 22, 2020
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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