DrugJul 29, 2020
Transliquid Technologies Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution recall — FDA D-1408-2020
Chemical Contamination: Presence of Undeclared Methanol
Class IFDA: TerminatedTransliquid Technologies, LLC
10,685drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 139
10,685 detailed records are currently available in this category.
DrugJul 29, 2020
Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz recall — FDA D-1417-2020
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Class IIFDA: TerminatedWALKER EMULSIONS Inc.
DrugJul 22, 2020
Preferred Pharmaceuticals Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch recall — FDA D-1390-2020
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Class IIFDA: TerminatedPreferred Pharmaceuticals, Inc.
DrugJul 22, 2020
Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles recall — FDA D-1382-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 22, 2020
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial recall — FDA D-1391-2020
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…
Class IIIFDA: TerminatedFresenius Kabi USA, LLC
DrugJul 22, 2020
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle recall — FDA D-1386-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class IIFDA: OngoingGranules Pharmaceuticals Inc.
DrugJul 22, 2020
Akorn Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle recall — FDA D-1388-2020
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Class IIIFDA: TerminatedAkorn, Inc.
DrugJul 22, 2020
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles recall — FDA D-1385-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 22, 2020
Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles recall — FDA D-1384-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 22, 2020
Auryxia (ferric citrate) tablets 210 mg recall — FDA D-1389-2020
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Class IIFDA: TerminatedKeryx Biopharmaceuticals, Inc.
DrugJul 22, 2020
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles recall — FDA D-1383-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 22, 2020
RemedyRepack Carbamazepine 200 mg Tablets, 100-unit dose tablets per box recall — FDA D-1387-2020
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Class IIFDA: TerminatedRemedyRepack Inc.
DrugJul 15, 2020
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle recall — FDA D-1374-2020
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class IIIFDA: TerminatedSOMERSET THERAPEUTICS LLC
DrugJul 15, 2020
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle recall — FDA D-1381-2020
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Class IIIFDA: TerminatedBiogen MA Inc.
DrugJul 15, 2020
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle recall — FDA D-1375-2020
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class IIIFDA: TerminatedSOMERSET THERAPEUTICS LLC
DrugJul 15, 2020
VistaPharm Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL recall — FDA D-1377-2020
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class IIIFDA: TerminatedVistaPharm, Inc.
DrugJul 15, 2020
VistaPharm Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. recall — FDA D-1378-2020
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class IIIFDA: TerminatedVistaPharm, Inc.
DrugJul 15, 2020
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle recall — FDA D-1373-2020
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class IIIFDA: TerminatedSOMERSET THERAPEUTICS LLC
DrugJul 15, 2020
Cetrotide recall — FDA D-1379-2020
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Class IIFDA: TerminatedEMD Serono, Inc.
DrugJul 8, 2020
Beaming White Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial recall — FDA D-1357-2020
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class IIFDA: TerminatedBeaming White LLC
DrugJul 8, 2020
The Harvard Drug Group Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 recall — FDA D-1360-2020
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugJul 8, 2020
Beaming White Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%) recall — FDA D-1358-2020
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class IIFDA: TerminatedBeaming White LLC
DrugJul 8, 2020
Glaxosmithkline Consumer Healthcare Holdings Childrens Dimetapp Cold & Cough, For ages 6 recall — FDA D-1362-2020
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Class IIFDA: TerminatedGlaxosmithkline Consumer Healthcare Holdings
DrugJul 8, 2020
Flexion Therapeutics Zilretta recall — FDA D-1376-2020
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Class IIIFDA: TerminatedFlexion Therapeutics, Inc.
How to use this drug recall index
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.