FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
County Fair Foods, Inc.
- Product
- Popcorn Pre-Pop in 8oz Polypropylene bag packaged 20 bags to…
- Reason
- Undeclared Yellow #5
- Published
- February 14, 2024
- Distribution
- Nationwide
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FDA 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
by Azurity Pharmaceuticals, Inc.
- Reason
- Labeling: Label Mix-up
- Published
- February 7, 2024
- Distribution
- Nationwide
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FDA 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.
by Den-Mat Holdings, LLC
- Reason
- CGMP Deviations: products may not conform to the labeled specifications.
- Published
- February 7, 2024
- Distribution
- Nationwide
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FDA 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.
by Den-Mat Holdings, LLC
- Reason
- CGMP Deviations: products may not conform to the labeled specifications.
- Published
- February 7, 2024
- Distribution
- Nationwide
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FDA 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
by Amerisource Health Services LLC
- Reason
- Failed Impurities/Degradation Specification.
- Published
- February 7, 2024
- Distribution
- Nationwide
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FDA 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.
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Published
- February 7, 2024
- Distribution
- Nationwide
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FDA 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.
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Published
- February 7, 2024
- Distribution
- Nationwide
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FDA 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.
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Published
- February 7, 2024
- Distribution
- Nationwide
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FDA 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.
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Published
- February 7, 2024
- Distribution
- Nationwide
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FDA 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.
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Published
- February 7, 2024
- Distribution
- Nationwide
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FDA 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.
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Published
- February 7, 2024
- Distribution
- Nationwide
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FDA 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
by Teva Pharmaceuticals USA, Inc
- Reason
- Failed Dissolution Specifications
- Published
- February 7, 2024
- Distribution
- Nationwide
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FDA 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
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- February 7, 2024
- Distribution
- Nationwide
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FDA 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
by Haleon US Holdings LLC
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- January 31, 2024
- Distribution
- Nationwide
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FDA 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
by Haleon US Holdings LLC
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- January 31, 2024
- Distribution
- Nationwide
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FDA 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.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Published
- January 31, 2024
- Distribution
- Nationwide
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FDA 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.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Published
- January 31, 2024
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, 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 47335-307-88.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Published
- January 31, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 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 47335-539-81.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Published
- January 31, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 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 47335-613-81.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Published
- January 31, 2024
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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