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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Benny Ts Vesta Inc dba Vesta Firey Gourmet Toppings
- Product
- the original BENNY T'S VESTA DRY HOT SAUCE VERY HOT NET WT.…
- Reason
- The firm was notified by the North Carolina Dept of Agriculture and Consumer Services that the product labeling does not include wheat and other ingredient common names in the ingredient statement.
- Published
- February 7, 2024
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Benny Ts Vesta Inc dba Vesta Firey Gourmet Toppings
- Product
- the original BENNY T'S VESTA DRY HOT SAUCE SCORPION NWT WT.…
- Reason
- The firm was notified by the North Carolina Dept of Agriculture and Consumer Services that the product labeling does not include wheat and other ingredient common names in the ingredient statement.
- Published
- February 7, 2024
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Benny Ts Vesta Inc dba Vesta Firey Gourmet Toppings
- Product
- the original BENNY T'S VESTA DRY HOT SAUCE REAPER NET WT. 1.…
- Reason
- The firm was notified by the North Carolina Dept of Agriculture and Consumer Services that the product labeling does not include wheat and other ingredient common names in the ingredient statement.
- Published
- February 7, 2024
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Benny Ts Vesta Inc dba Vesta Firey Gourmet Toppings
- Product
- the original BENNY T'S VESTA DRY HOT SAUCE HOT NET WT. 1.5OZ…
- Reason
- The firm was notified by the North Carolina Dept of Agriculture and Consumer Services that the product labeling does not include wheat and other ingredient common names in the ingredient statement.
- Published
- February 7, 2024
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Benny Ts Vesta Inc dba Vesta Firey Gourmet Toppings
- Product
- the original BENNY T'S VESTA DRY HOT SAUCE GHOST NET WT. 1.5…
- Reason
- The firm was notified by the North Carolina Dept of Agriculture and Consumer Services that the product labeling does not include wheat and other ingredient common names in the ingredient statement.
- Published
- February 7, 2024
- Distribution
- Product was shipped to the following sta…
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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 →
FDA Recall
Completed
Historical recordClass II
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, 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 63304-175-13.
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.
Read the full medical disclaimer.