DrugAug 28, 2024
Zeco HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol) recall — FDA D-0640-2024
CGMP Deviations: sterile water not used for production
Class IIFDA: CompletedZeco LLC
Recall records from August 2024
These records include useful source details for the selected month.
DrugAug 28, 2024
Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For recall — FDA D-0635-2024
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Class IFDA: OngoingHikma Pharmaceuticals USA Inc.
DrugAug 28, 2024
ACETAMINOPHEN ASPIRIN AND CAFFEINE Healthy Living Acetaminophen, Aspirin (NSAID) and recall — FDA D-0641-2024
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Class IFDA: OngoingAurobindo Pharma USA Inc
DrugAug 28, 2024
Timolol Maleate Ophthalmic Solution USP, 0.5% recall — FDA D-0642-2024
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class IIFDA: OngoingFDC Limited
DrugAug 28, 2024
Zeco Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic recall — FDA D-0639-2024
CGMP Deviations: sterile water not used for production
Class IIFDA: CompletedZeco LLC
DrugAug 21, 2024
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles recall — FDA D-0632-2024
Defective container; yellow colored spike from cap lodged in the nozzle
Class IIFDA: OngoingFDC Limited
DrugAug 21, 2024
Taro Pharmaceuticals U.S.A Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle recall — FDA D-0633-2024
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained…
Class IIIFDA: CompletedTaro Pharmaceuticals U.S.A., Inc.
DrugAug 14, 2024
Gabapentin Tablets, USP, 600 mg, 500-count bottles recall — FDA D-0634-2024
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Class IIFDA: TerminatedGranules Pharmaceuticals Inc.
DrugAug 14, 2024
Sevelamer Carbonate for Oral Suspension 0.8g packets recall — FDA D-0625-2024
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Class IIIFDA: OngoingDr. Reddy's Laboratories, Inc.
DrugAug 14, 2024
Amneal Pharmaceuticals Methotrexate Tablets, USP, 2.5mg, 100-count Bottle recall — FDA D-0629-2024
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Class IIIFDA: CompletedAmneal Pharmaceuticals, LLC
DrugAug 14, 2024
Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles recall — FDA D-0631-2024
Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Class IFDA: TerminatedA-S Medication Solutions LLC
DrugAug 14, 2024
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial recall — FDA D-0630-2024
Lack of Assurance of Sterility
Class IIFDA: TerminatedEMPOWER CLINIC SERVICES LLC
DrugAug 14, 2024
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and recall — FDA D-0628-2024
Defective container: potential for non-sealed pouches which can lead to product leakage.
Class IIIFDA: TerminatedNovel Laboratories, Inc. d.b.a Lupin Somerset
DrugAug 14, 2024
Granules Consumer Health Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra recall — FDA D-0627-2024
Label mix-up: Carton incorrectly labeled.
Class IIIFDA: TerminatedGranules Consumer Health Inc.
DrugAug 7, 2024
Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial recall — FDA D-0624-2024
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class IIFDA: OngoingEugia US LLC
VehicleAug 1, 2024
BMW starter motor recall — NHTSA campaign 24V576000
BMW of North America, LLC is recalling certain 2019-2020 X5, X7, 2020 3 Series Sedan, X6, 2020-2021 7 Series Sedan, 2020 8 Series Convertible, 8 Series Coupe, and 2020 8 Series Gran Coupe…
starter motorBMW of North America, LLC
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.