Drug and pharmaceutical recalls

17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2020-08-05FDA-DrugMasterPharm LLCClass II
Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Progesterone 300 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Progesterone (Modified Release) 150 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15 mL), b) 2 FL OZ (60 mL) bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15 mL) bottle MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600.
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Finasteride Plus 1.25mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Estriol 6 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugMasterPharm LLCClass II
Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lack of Processing Controls (lack of assurance of conformity to specifications).
2020-08-05FDA-DrugLupin Pharmaceuticals Inc.Class II
Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
2020-08-05FDA-DrugPOLARIZED LLCClass 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.
CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
2020-08-05FDA-DrugWORLD EVENT PROMOTIONS, LLCClass II
Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC 612520481094
Subpotent Drug: Product was found to be subpotent. Product also has high pH levels
2020-08-05FDA-DrugAllergan PLCClass 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
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
2020-08-05FDA-DrugAllergan PLCClass 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
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
2020-08-05FDA-DrugUVT INCClass 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.
Chemical Contamination: Product contains undeclared methanol.
2020-07-29FDA-DrugWALKER EMULSIONS INCClass II
Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
2020-07-29FDA-DrugWALKER EMULSIONS INCClass II
Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
2020-07-29FDA-DrugTransliquid Technologies, LLCClass 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
Chemical Contamination: Presence of Undeclared Methanol
2020-07-29FDA-DrugLupin Pharmaceuticals Inc.Class 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
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
2020-07-29FDA-DrugHF Acquisition Co. LLCClass III
Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
2020-07-22FDA-DrugFresenius Kabi USA, LLCClass 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
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.
2020-07-22FDA-DrugPreferred Pharmaceuticals, Inc.Class 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.
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
2020-07-22FDA-DrugKeryx Biopharmaceuticals, Inc.Class 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.
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.

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