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…
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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…
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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
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 →
FDA Recall
Completed
Historical recordClass II
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.
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
Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-639-83.
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
Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.
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
Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83.
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
Cinacalcet Tablets 60mg, Rx Only, 30 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 47335-380-83.
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
Terminated
Historical recordClass II
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.
by BE PHARMACEUTICALS AG
- Reason
- Lack of Sterility Assurance: Aseptic process simulation failure.
- Published
- January 31, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18
by Pfizer
- Reason
- Presence of particulate matter: glass
- 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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