FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Russell Stover Candies Inc
- Product
- Russel Stover Sugar Free Peanut Butter Cups packaged in 2.4o…
- Reason
- Outer package is mislabeled and does not declare tree nuts (pecans).
- Published
- March 29, 2023
- Distribution
- Distributors in AL, CA, FL, GA, IN, KY,…
View recall →
FDA Recall
Terminated
Historical recordClass II
Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 678112000708; NDC 67172-504-01.
by Teva Pharmaceuticals USA Inc
- Reason
- Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
- Published
- March 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7079-05
by AVEVA Drug Delivery Systems, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
- Published
- March 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05
by AVEVA Drug Delivery Systems, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
- Published
- March 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27
by Padagis US LLC
- Reason
- Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
- Published
- March 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-901-01
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Potential risk of Cross Contamination
- Published
- March 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Potential risk of Cross Contamination
- Published
- March 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Potential risk of Cross Contamination
- Published
- March 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Potential risk of Cross Contamination
- Published
- March 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Potential risk of Cross Contamination
- Published
- March 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Potential risk of Cross Contamination
- Published
- March 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Epic Baking
- Product
- Cafe' Intermezzo Red Velvet Torte 5.5 lbs Ingredients: Red V…
- Reason
- Firm did not list sub-ingredients. Undeclared Red 40. Remaining major allergens were listed in contains statement and/or ingredient list.
- Published
- March 22, 2023
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Epic Baking
- Product
- Cafe' Intermezzo Key Lime Cheesecake 6.5 lbs Ingredients: Cr…
- Reason
- Firm did not list sub-ingredients. Undeclared Yellow 5 and Blue 1. Remaining major allergens were listed in contains statement and/or ingredient list.
- Published
- March 22, 2023
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Baily International Foods
- Product
- Canton Dry Noodle, packaged in 30lb. corrugated (cardboard)…
- Reason
- Peanut contamination (in sub ingredient)
- Published
- March 22, 2023
- Distribution
- Distributed to wholesalers in CO, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Baily International Foods
- Product
- Wonton wrappers, 4" x 4" and 3.5" x 3.5", packaged in 30lb.…
- Reason
- Peanut contamination (in sub ingredient)
- Published
- March 22, 2023
- Distribution
- Distributed to wholesalers in CO, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Baily International Foods
- Product
- Egg roll wrappers, 6" x 6" and 7" x 7", packaged in 30lb. co…
- Reason
- Peanut contamination (in sub ingredient)
- Published
- March 22, 2023
- Distribution
- Distributed to wholesalers in CO, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Navada Imports
- Product
- Soybean Lecithin Powder Packaged in 44 lb. (20 kg.) boxes
- Reason
- Undeclared peanut allergen
- Published
- March 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Navada Imports
- Product
- Sunflower Lecithin Powder Packaged in 44 lb. (20 kg.) boxes
- Reason
- Undeclared peanut allergen
- Published
- March 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Epic Baking
- Product
- Cafe' Intermezzo White Chocolate Raspberry Cheesecake 6 lbs…
- Reason
- Firm did not list sub-ingredients. All major allergens were listed in contains statement and/or ingredient list.
- Published
- March 22, 2023
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Epic Baking
- Product
- Cafe' Intermezzo White Chocolate Amaretto Cheesecake 7 lbs I…
- Reason
- Label does not list sub ingredients that include allergens. Label states, "May contain tree nuts" when the product actually contains almonds.
- Published
- March 22, 2023
- Distribution
- Product was shipped to the following sta…
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.