Drug Recall Terminated Historical recordClass II
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
- Reason
- CGMP Deviations
- Recall initiated
- January 19, 2024
- Reported by FDA
- February 14, 2024
- Distribution
- US Nationwide
FDA Drug Recalls
Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.
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Drug Recall Terminated Historical recordClass I
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
- Reason
- Labeling: Label Mix-up
- Recall initiated
- January 4, 2024
- Reported by FDA
- February 7, 2024
- Distribution
- USA nationwide
Drug Recall Ongoing Historical recordClass II
Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436.
- Reason
- CGMP Deviations: products may not conform to the labeled specifications.
- Recall initiated
- January 16, 2024
- Reported by FDA
- February 7, 2024
- Distribution
- Nationwide in the US
Drug Recall Ongoing Historical recordClass II
OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.
- Reason
- CGMP Deviations: products may not conform to the labeled specifications.
- Recall initiated
- January 16, 2024
- Reported by FDA
- February 7, 2024
- Distribution
- Nationwide in the US
Drug Recall Terminated Historical recordClass II
Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11
- Reason
- Failed Impurities/Degradation Specification.
- Recall initiated
- January 11, 2024
- Reported by FDA
- February 7, 2024
- Distribution
- Nationwide in the USA
Drug Recall Terminated Historical recordClass II
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
- Reason
- Subpotent Drug and Failed Impurities/Degradation Specifications
- Recall initiated
- January 5, 2024
- Reported by FDA
- February 7, 2024
- Distribution
- Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
Drug Recall Terminated Historical recordClass II
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06
- Reason
- Subpotent Drug and Failed Impurities/Degradation Specifications
- Recall initiated
- January 5, 2024
- Reported by FDA
- February 7, 2024
- Distribution
- Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
Drug Recall Ongoing Historical recordClass I
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
- Reason
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Recall initiated
- December 28, 2023
- Reported by FDA
- February 7, 2024
- Distribution
- Nationwide within the United States
Drug Recall Ongoing Historical recordClass I
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
- Reason
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Recall initiated
- December 28, 2023
- Reported by FDA
- February 7, 2024
- Distribution
- Nationwide within the United States
Drug Recall Ongoing Historical recordClass I
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
- Reason
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Recall initiated
- December 28, 2023
- Reported by FDA
- February 7, 2024
- Distribution
- Nationwide within the United States
Drug Recall Ongoing Historical recordClass I
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
- Reason
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Recall initiated
- December 28, 2023
- Reported by FDA
- February 7, 2024
- Distribution
- Nationwide within the United States
Drug Recall Ongoing Historical recordClass I
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
- Reason
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Recall initiated
- December 28, 2023
- Reported by FDA
- February 7, 2024
- Distribution
- Nationwide within the United States
Drug Recall Ongoing Historical recordClass I
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
- Reason
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Recall initiated
- December 28, 2023
- Reported by FDA
- February 7, 2024
- Distribution
- Nationwide within the United States
Drug Recall Terminated Historical recordClass II
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
- Reason
- Failed Dissolution Specifications
- Recall initiated
- January 12, 2024
- Reported by FDA
- February 7, 2024
- Distribution
- Illinois only
Drug Recall Ongoing Historical recordClass II
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30
- Reason
- Failed Dissolution Specifications
- Recall initiated
- January 8, 2024
- Reported by FDA
- February 7, 2024
- Distribution
- Nationwide
Drug Recall Terminated Historical recordClass II
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
- Reason
- Failed Impurities/Degradation Specifications
- Recall initiated
- January 3, 2024
- Reported by FDA
- February 7, 2024
- Distribution
- Nationwide in the USA
Drug Recall Ongoing Historical recordClass I
Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
- Reason
- Microbial Contamination of Non-Sterile Products
- Recall initiated
- December 26, 2023
- Reported by FDA
- January 31, 2024
- Distribution
- USA nationwide
Drug Recall Ongoing Historical recordClass I
Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
- Reason
- Microbial Contamination of Non-Sterile Products
- Recall initiated
- December 26, 2023
- Reported by FDA
- January 31, 2024
- Distribution
- USA nationwide
Drug Recall Completed Historical recordClass II
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.
- Reason
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Recall initiated
- January 18, 2024
- Reported by FDA
- January 31, 2024
- Distribution
- Nationwide in the USA
Drug Recall Completed Historical recordClass II
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88.
- Reason
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Recall initiated
- January 18, 2024
- Reported by FDA
- January 31, 2024
- Distribution
- Nationwide in the USA
Data last updated:
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.
