Drug and pharmaceutical recalls
17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2024-04-03FDA-DrugSCA Pharmaceuticals, LLCClass IIfentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132
Lack of Assurance of Sterility
- 2024-04-03FDA-DrugSCA Pharmaceuticals, LLCClass IIfentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
Lack of Assurance of Sterility
- 2024-04-03FDA-DrugSCA Pharmaceuticals, LLCClass IIfentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940
Lack of Assurance of Sterility
- 2024-04-03FDA-DrugSCA Pharmaceuticals, LLCClass IIDiltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
Lack of Assurance of Sterility
- 2024-03-27FDA-DrugSuper Chill ProductsClass INeptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
- 2024-03-27FDA-DrugHikma Pharmaceuticals USA Inc.Class IIInfumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
- 2024-03-27FDA-DrugEugia US LLCClass IINicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- 2024-03-27FDA-DrugEugia US LLCClass IINicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- 2024-03-27FDA-DrugNovitium Pharma LLCClass IIIDigoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20
Cross Contamination with Other Products:(mycophenolate mofetil).
- 2024-03-20FDA-DrugMicro Labs LimitedClass IITelmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.
Failed Stability Specifications: Out of specification for blend uniformity.
- 2024-03-20FDA-DrugGlobal CorporationClass IIBroncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
- 2024-03-20FDA-DrugGlobal CorporationClass IIBroncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
- 2024-03-20FDA-DrugEugia US LLCClass IITobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01.
Failed Stability Specification: Water determination was found not complying with specification.
- 2024-03-20FDA-DrugOptikem International, Inc.Class IIhyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150
Lack of Assurance of Sterility
- 2024-03-20FDA-DrugOptikem International, Inc.Class IITRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.
Lack of Assurance of Sterility
- 2024-03-20FDA-DrugOptikem International, Inc.Class IITRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.
Lack of Assurance of Sterility
- 2024-03-20FDA-DrugOptikem International, Inc.Class IITRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.
Lack of Assurance of Sterility
- 2024-03-20FDA-DrugOptikem International, Inc.Class IITRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.
Lack of Assurance of Sterility
- 2024-03-20FDA-DrugOptikem International, Inc.Class IITRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.
Lack of Assurance of Sterility
- 2024-03-20FDA-DrugOptikem International, Inc.Class IITRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.
Lack of Assurance of Sterility
- 2024-03-20FDA-DrugOptikem International, Inc.Class IITRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.
Lack of Assurance of Sterility
- 2024-03-20FDA-DrugOptikem International, Inc.Class IITRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.
Lack of Assurance of Sterility
- 2024-03-20FDA-DrugOptikem International, Inc.Class IITRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.
Lack of Assurance of Sterility
- 2024-03-20FDA-DrugThea Pharma, Inc.Class IIBetimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
- 2024-03-20FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIBicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
cGMP Deviations: Products were stored outside the drug label specifications.
- 2024-03-20FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIInfuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
cGMP Deviations: Products were stored outside the drug label specifications.
- 2024-03-20FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIRocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
cGMP Deviations: Products were stored outside the drug label specifications.
- 2024-03-20FDA-DrugB. Braun Medical IncClass IIPotassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
- 2024-03-20FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIFebuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-03-20FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIFebuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
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