Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0024-2021 | 07-11-2020 | blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4 c) 15.2 fl oz (450 ml) bottle, UPC 8 14266 02392 1, d) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6, e) 18 fl oz / 532 ml bottle, UPC 8 14266 02391 4, f) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3 g) 70 fl oz / 2.07L bottle, UPC 8 14266 02367 9 h) 1.05 GAL / 4L bottle, UPC 8 14266 02368 6; Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-0028-2021 | 07-11-2020 | Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7 | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-0027-2021 | 07-11-2020 | ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) 10 fL oz / 295 ml bottle, UPC 6 39277 49070 4, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-0023-2021 | 07-11-2020 | blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b) 7.5 fl. oz./221 ml bottle, UPC 8 14266 02362 4 b) 33.8 fl. oz./1L bottle, UPC 8 14266 02369 3, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-0030-2021 | 07-11-2020 | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bottle, Distributed in USA and Canada by: 4e Brands 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico. UPC 8 14266 02374 7 | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content. | 4e Brands North America, Llc / N/A | Class I | Terminated |
| D-1389-2020 | 07-10-2020 | 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. Package NDCs: 59922-631-01 | cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia. | Keryx Biopharmaceuticals, Inc. / 59,820 bottles | Class II | Terminated |
| D-1565-2020 | 07-09-2020 | Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01 | CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol. | Maquiladora Miniara Sa De Cv / 245,500 bottles | Class II | Terminated |
| D-0266-2021 | 07-07-2020 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415 | Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 36 cartons | Class I | Terminated |
| D-0265-2021 | 07-07-2020 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400 Package NDCs: 54365-400-32 | Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 988 cartons | Class I | Terminated |
| D-0268-2021 | 07-07-2020 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415 Package NDCs: 54365-400-33 | Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 400 cartons | Class I | Terminated |
| D-1382-2020 | 07-07-2020 | Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01 Package NDCs: 68180-338-01; 68180-338-02; 68180-338-03; 68180-339-09; 68180-339-01; 68180-339-02 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Lupin Pharmaceuticals Inc. / 64,344 bottles | Class II | Terminated |
| D-1385-2020 | 07-07-2020 | Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07 Package NDCs: 68180-336-07; 68180-336-02; 68180-336-01; 68180-337-07; 68180-337-01; 68180-337-02 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Lupin Pharmaceuticals Inc. / 273,060 bottles | Class II | Terminated |
| D-1383-2020 | 07-07-2020 | Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09 Package NDCs: 68180-338-01; 68180-338-02; 68180-338-03; 68180-339-09; 68180-339-01; 68180-339-02 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Lupin Pharmaceuticals Inc. / 95,886 bottles | Class II | Terminated |
| D-1484-2020 | 07-07-2020 | Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50 Package NDCs: 67457-813-50 | Presence of Particulate Matter | Mylan Institutional LLC / 18,480 vials | Class I | Terminated |
| D-0267-2021 | 07-07-2020 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400 | Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 280 cartons | Class I | Terminated |
| D-1384-2020 | 07-07-2020 | Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07 Package NDCs: 68180-336-07; 68180-336-02; 68180-336-01; 68180-337-07; 68180-337-01; 68180-337-02 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Lupin Pharmaceuticals Inc. / 59,568 bottles | Class II | Terminated |
| D-1445-2020 | 07-06-2020 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86 | Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine | SUN PHARMACEUTICAL INDUSTRIES INC / 3516 bottles | Class III | Terminated |
| D-1409-2020 | 07-06-2020 | 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. | Allergan PLC / 4,018 bottles | Class III | Terminated |
| D-1410-2020 | 07-06-2020 | 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. | Allergan PLC / 8,555 kits | Class III | Terminated |
| D-1386-2020 | 07-03-2020 | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India Package NDCs: 70010-491-01; 70010-491-05; 70010-491-10; 70010-491-18; 70010-491-19; 70010-491-09; 70010-492-01; 70010-492-05; 70010-492-20; 70010-492-21 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Granules Pharmaceuticals Inc / a) 476,073 bottles; b) 2,100 bottles | Class II | Ongoing |
| D-1406-2020 | 07-02-2020 | 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 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples. | Lupin Pharmaceuticals Inc. / 35,928 bottles | Class II | Terminated |
| D-1419-2020 | 07-02-2020 | 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). | MasterPharm LLC / 390 capsules | Class II | Terminated |
| D-1430-2020 | 07-02-2020 | 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). | MasterPharm LLC / 288 tablets | Class II | Terminated |
| D-1421-2020 | 07-02-2020 | 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). | MasterPharm LLC / 300 capsules | Class II | Terminated |
| D-1418-2020 | 07-02-2020 | 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). | MasterPharm LLC / 24 grams | Class II | Terminated |
| D-1437-2020 | 07-02-2020 | Tadalafil 18 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). | MasterPharm LLC / 900 capsules | Class II | Terminated |
| D-1442-2020 | 07-02-2020 | Vardenafil 20 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). | MasterPharm LLC / 134 troches | Class II | Terminated |
| D-1435-2020 | 07-02-2020 | Sildenafil 50 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). | MasterPharm LLC / 80 troches | Class II | Terminated |
| D-1438-2020 | 07-02-2020 | Tadalafil 26 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). | MasterPharm LLC / 900 capsules | Class II | Terminated |
| D-1429-2020 | 07-02-2020 | 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). | MasterPharm LLC / 90 trouches | Class II | Terminated |
| D-1431-2020 | 07-02-2020 | 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). | MasterPharm LLC / 300 troches | Class II | Terminated |
| D-1434-2020 | 07-02-2020 | Progesterone Modified Release 200 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). | MasterPharm LLC / 900 capsules | Class II | Terminated |
| D-1443-2020 | 07-02-2020 | Yohimbine HCL 5.4mg 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). | MasterPharm LLC / 90 capsules | Class II | Terminated |
| D-1439-2020 | 07-02-2020 | Tadalafil 3 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). | MasterPharm LLC / 900 capsules | Class II | Terminated |
| D-1420-2020 | 07-02-2020 | 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). | MasterPharm LLC / 90 capsules | Class II | Terminated |
| D-1432-2020 | 07-02-2020 | 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). | MasterPharm LLC / 300 capsules | Class II | Terminated |
| D-1433-2020 | 07-02-2020 | 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). | MasterPharm LLC / 600 capsules | Class II | Terminated |
| D-1422-2020 | 07-02-2020 | 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). | MasterPharm LLC / 29580 capsules | Class II | Terminated |
| D-1440-2020 | 07-02-2020 | Tadalafil 7 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). | MasterPharm LLC / 12000 capsules | Class II | Terminated |
| D-1426-2020 | 07-02-2020 | 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). | MasterPharm LLC / 1200 capsules | Class II | Terminated |
| D-1570-2020 | 07-02-2020 | bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5 | Chemical Contamination: Product contains methanol. | AAA Cosmetica, SA de CV / 204,768 bottles | Class I | Terminated |
| D-1427-2020 | 07-02-2020 | 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). | MasterPharm LLC / 600 capsules | Class II | Terminated |
| D-1569-2020 | 07-02-2020 | bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5 | CGMP Deviations | AAA Cosmetica, SA de CV / 21,228 bottles | Class II | Terminated |
| D-1424-2020 | 07-02-2020 | 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). | MasterPharm LLC / 543 units | Class II | Terminated |
| D-1428-2020 | 07-02-2020 | 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). | MasterPharm LLC / 330 troches | Class II | Terminated |
| D-1441-2020 | 07-02-2020 | Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets 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). | MasterPharm LLC / 339 pellets | Class II | Terminated |
| D-1425-2020 | 07-02-2020 | 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). | MasterPharm LLC / 300 capsules | Class II | Terminated |
| D-1423-2020 | 07-02-2020 | 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). | MasterPharm LLC / 462 units | Class II | Terminated |
| D-1436-2020 | 07-02-2020 | Tadalafil 12 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). | MasterPharm LLC / 600 capsules | Class II | Terminated |
| D-1562-2020 | 07-02-2020 | Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01 | Labeling: Label Error on Declared Strength | Edge Pharma, LLC / 5 IV bags | Class II | Terminated |
| D-1503-2020 | 07-01-2020 | Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and Industrial Use Only, a) foamyiQ 42.27 oz/1250 mL cartridge, UPC code: 7 53727 26454 4; b) Lite 'n Foamy 1 gallon/3.79 L container UPC code: 7 53727 26113 0, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. | Microbial contamination of non-sterile products: positive microbial contamination in product. | Spartan Chemical Co Inc / a) 60,796 cartridges, b) 420 gallon containers | Class I | Terminated |
| D-1390-2020 | 07-01-2020 | 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. | Preferred Pharmaceuticals, Inc. / N/A | Class II | Terminated |
| D-1387-2020 | 06-29-2020 | Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose. | FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing. | RemedyRepack Inc. / 498 tablets | Class II | Terminated |
| D-1408-2020 | 06-29-2020 | 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 | Transliquid Technologies, LLC / 20,340 bottles | Class I | Terminated |
| D-1379-2020 | 06-29-2020 | Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1 Package NDCs: 44087-1225-1 | Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance. | EMD Serono, Inc. / 30,756 vials | Class II | Terminated |
| D-1412-2020 | 06-25-2020 | 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. | POLARIZED LLC / 18, 126 bottles | Class II | Terminated |
| D-1534-2020 | 06-24-2020 | Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0 | Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches | Medichem S.A. / 117,800 kg | Class I | Terminated |
| D-1538-2020 | 06-23-2020 | All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico Japon 50 Celaya, Gto. Mexico 38010, Distributed by All Clean Natural LTD, UPC Code 6 28055 37013 0 | Chemical Contamination: Product contains undeclared methanol. | Itech 361 LLC / 18,760 bottles | Class I | Terminated |
| D-1509-2020 | 06-23-2020 | BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32 Package NDCs: 54365-400-32 | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | CareFusion 213, LLC / 12,500 applicators | Class I | Terminated |
| D-1511-2020 | 06-23-2020 | ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01 | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | CareFusion 213, LLC / 4,272,300 applicators | Class I | Terminated |
| D-1377-2020 | 06-23-2020 | Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99. | Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. | VistaPharm, Inc. / 380,700 cups | Class III | Terminated |
| D-1381-2020 | 06-23-2020 | Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02 Package NDCs: 64406-007-03; 64406-005-01; 64406-006-02 | cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. | Biogen MA Inc. / 3,922 bottles | Class III | Terminated |
| D-1378-2020 | 06-23-2020 | Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16. | Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. | VistaPharm, Inc. / 14,760 bottles | Class III | Terminated |
| D-1510-2020 | 06-23-2020 | ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11 | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | CareFusion 213, LLC / 2,800,800 applicators | Class I | Terminated |
| D-1407-2020 | 06-22-2020 | 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. | UVT INC / 38,016 bottles | Class I | Terminated |
| D-1447-2020 | 06-18-2020 | Tasty Drops Hemp Oil Extract, Natural, 1 FL. OZ (30ML) bottles, 500mg CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29084 2 | Chemical Contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 220 bottles | Class I | Completed |
| D-1468-2020 | 06-18-2020 | Acadia Farms, Equilibrium, vermont maple, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles, Distributed by: Acadia Farms, Rehobeth, Massachusetts | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1470-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Berry, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29083 5 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 201 bottles | Class I | Completed |
| D-1461-2020 | 06-18-2020 | Goodness Gurus, Healthy Hemp Drops, 500MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6 53341 99261 1 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 150 bottles | Class I | Completed |
| D-1482-2020 | 06-18-2020 | Herbzeedy, Hemp Oil Full Spectrum, Natural, 1500 MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Herbzeedy, Statesboro, GA | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 33 bottles | Class I | Completed |
| D-1479-2020 | 06-18-2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural, 1000MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 25 bottles | Class I | Completed |
| D-1453-2020 | 06-18-2020 | Made by Hemp 1000MG Hemp Extract, Strawberry Creme, 1 OZ (30 ML) bottles, Dist by: MHR Brands, Jenison, MI, UPC 8 02991 76554 4 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 496 bottles | Class I | Completed |
| D-1450-2020 | 06-18-2020 | Tasty Drops Hemp Oil Extract, Vanilla, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76471 4 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 104 bottles | Class I | Completed |
| D-1448-2020 | 06-18-2020 | Tasty Drops Hemp Oil Extract, Berry, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76469 1 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 213 bottles | Class I | Completed |
| D-1459-2020 | 06-18-2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Spearmint, 500mg CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 25 bottles | Class I | Completed |
| D-1481-2020 | 06-18-2020 | Goodness Gurus, Healthy Hemp Drops, 1500 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6 53341 99411 0 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 50 bottles | Class I | Completed |
| D-1469-2020 | 06-18-2020 | Acadia Farms, Serenity, soothing mint, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles, Distributed by: Acadia Farms, Rehobeth, Massachusetts | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1471-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Berry, 1500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29087 3 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 150 bottles | Class I | Completed |
| D-1454-2020 | 06-18-2020 | A Clean Choice CBD, Hemp Oil Extract Tincture, French Vanilla, 1000 mg, 1 fl oz (30 ml) bottles, Made in Michigan for A Clean Choice, A Division of A Clean Cigarette, Inc., 3055 Bay Road Suite 1, Saginaw, MI 48603 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 350 bottles | Class I | Completed |
| D-1480-2020 | 06-18-2020 | Goodness Gurus, Healthy Hemp Drops Full Strength, 1000 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 53341 99311 3 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 50 bottles | Class I | Completed |
| D-1467-2020 | 06-18-2020 | Recovery Releaf, Pure CBD Oil, Vanilla, 1000MG, 25MG per serving, 1 fl. oz (30 ml) bottles,Distributed by: Recovery Releaf, West Palm Beach, FL | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1473-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29081 1 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 366 bottles | Class I | Completed |
| D-1472-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Natural, 1500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29088 0 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1455-2020 | 06-18-2020 | A Clean Choice CBD, Hemp Oil Extract Tincture, Strawberry Creme, 1000mg, 1 fl oz (30 ml) bottles, Made in Michigan for A Clean Choice, A Division of A Clean Cigarette, Inc., 3055 Bay Rd Suite 1, Saginaw, MI 48603 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 350 bottles | Class I | Completed |
| D-1451-2020 | 06-18-2020 | Made by Hemp 1000MG Hemp Extract, French Vanilla, 1 OZ (30 ML) bottles, Dist by: MHR Brands, Jenison, MI, UPC 8 02991 76553 7 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 495 bottles | Class I | Completed |
| D-1457-2020 | 06-18-2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Berry Blast, 500mg CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 146, Eau Claire, MI 49111 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 25 bottles | Class I | Completed |
| D-1463-2020 | 06-18-2020 | Javan Anti Aging and Wellness Institute, CBD Oil, Full Spectrum Hemp Oil, Spearmint, 300MG CBD, 1 FL. OZ (30 ML) bottles, Dist by: Javan Wellness LLC, 1445 Church St NW Unit 24, Washington, DC 20005 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1462-2020 | 06-18-2020 | Herbzeedy, Hemp Oil Full Spectrum, Natural, 500 MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Herbzeedy, Statesboro, GA | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 134 bottles | Class I | Completed |
| D-1464-2020 | 06-18-2020 | Pathway To Wellness, CBD Oil, Premium Hemp Oil Drops, Natural, 1000MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Pathway to Wellness | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1452-2020 | 06-18-2020 | Made by Hemp 1000MG Hemp Extract, Mojito Lime, 1 OZ (30 ML) bottles, Dist by: MHR Brandsl, Jenison, M,I UPC 8 02991 76552 0 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 486 bottles | Class I | Completed |
| D-1458-2020 | 06-18-2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural 500MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 72 bottles | Class I | Completed |
| D-1478-2020 | 06-18-2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil , Berry Blast, 1000MG CBD, 1 FL. OZ (30ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 50 bottles | Class I | Completed |
| D-1460-2020 | 06-18-2020 | Goodness Gurus, Healthy Hemp Drops, 500MG/Berry, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6 53341 99271 0 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 50 bottles | Class I | Completed |
| D-1474-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 1000MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76539 1 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 391 bottles | Class I | Completed |
| D-1476-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Vanilla, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29082 8 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 152 bottles | Class I | Completed |
| D-1466-2020 | 06-18-2020 | SP, hemp oil, Spearmint, 300MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: The Spiffy Piff | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 25 bottles | Class I | Completed |
| D-1465-2020 | 06-18-2020 | SP, hemp oil, Berry, 300MG CBD,1 FL. OZ (30 ML) bottles, Distributed by: The Spiffy Piff | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 25 bottles | Class I | Completed |
| D-1477-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Vanilla, 1500MG CBD,1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29086 6 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1475-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 1500MG CBD,1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29085 9 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 250 bottles | Class I | Completed |
| D-1449-2020 | 06-18-2020 | Tasty Drops Hemp Oil Extract, Spearmint, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76472 1 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / | Class I | Completed |
