FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Health Matters America Inc.
- Product
- Organic traditions brand DARK CHOCOLATE HAZELNUTS WITH CHILI…
- Reason
- The imported products were found to contain undeclared milk (casein) based on analyses by the Canadian Food Inspection Agency (CFIA).
- Published
- December 13, 2017
- Distribution
- Retail stores located in Arizona, Califo…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Health Matters America Inc.
- Product
- Organic traditions brand DARK CHOCOLATE HAZELNUTS, NET WT.…
- Reason
- The imported products were found to contain undeclared milk (casein) based on analyses by the Canadian Food Inspection Agency (CFIA).
- Published
- December 13, 2017
- Distribution
- Retail stores located in Arizona, Califo…
View recall →
FDA Recall
Terminated
Historical recordClass II
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
by Zydus Pharmaceuticals USA Inc
- Reason
- Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
- Published
- December 6, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0.
by EAI-JR286 INC
- Reason
- CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
- Published
- December 6, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
by Mayne Pharma Inc
- Reason
- Failed Dissolution Specifications.
- Published
- December 6, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Dissolution Specification
- Published
- December 6, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05
by Teva Pharmaceuticals USA
- Reason
- Failed Tablet/Capsule Specifications; potential presence of broken tablets.
- Published
- December 6, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reese Pharmaceutical Company
- Product
- Orange Flavor Immune Support Dietary Supplement Effervescent…
- Reason
- The label does not list "Sodium" in the ingredient statement.
- Published
- December 6, 2017
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reese Pharmaceutical Company
- Product
- Berry Flavor Immune Support Dietary Supplement Effervescent…
- Reason
- The label does not list "Sodium" in the ingredient statement.
- Published
- December 6, 2017
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dutch Valley Food Distributors Inc.
- Product
- Dark Chocolate Cashew, Net 11 oz., Contains Cashew and Soy,…
- Reason
- Our supplier, GKI, did not have milk declared as an allergen on an item we repackage. Therefore our labels did not contain milk
- Published
- December 6, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dutch Valley Food Distributors Inc.
- Product
- Dark Chocolate Almond, Net 11 oz., Contains Almond and Soy,…
- Reason
- Our supplier, GKI, did not have milk declared as an allergen on an item we repackage. Therefore our labels did not contain milk
- Published
- December 6, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass III
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
by West-Ward Pharmaceuticals Corp.
- Reason
- Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
- Published
- November 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
by West-Ward Pharmaceuticals Corp.
- Reason
- Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
- Published
- November 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01
by Amerisource Health Services
- Reason
- Presence of Foreign Tablets/Capsules.
- Published
- November 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
by Leading Pharma, LLC
- Reason
- Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
- Published
- November 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Seattle Gourmet Foods Inc.
- Product
- Dilettante Chocolates Espresso Blend, Espresso Beans in Semi…
- Reason
- Costco item # 2335, Dilettante Chocolates Espresso Blend, Espresso Beans in Semisweet, Milk and White Chocolate is recalled because it may contain undeclared almonds.
- Published
- November 29, 2017
- Distribution
- distributed in Utah and Washington
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Shoreline Fruit, LLC
- Product
- Shoreline Fruit Dark Choc Covered Montmorency Cherries packa…
- Reason
- Shoreline Fruit is voluntarily recalling select Shoreline Fruit bulk and Cherry Bay Orchards branded dark chocolate coated cherry products due to supplier's recall of undeclared allergen milk in dark chocolate.
- Published
- November 29, 2017
- Distribution
- Domestic: AK AL AR AZ CA CO CT DC…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Shoreline Fruit, LLC
- Product
- Dried Dark Chocolate Covered Cherries, The products are pack…
- Reason
- Shoreline Fruit is voluntarily recalling select Shoreline Fruit bulk and Cherry Bay Orchards branded dark chocolate coated cherry products due to supplier's recall of undeclared allergen milk in dark chocolate.
- Published
- November 29, 2017
- Distribution
- Domestic: AK AL AR AZ CA CO CT DC…
View recall →
FDA Recall
Terminated
Historical recordClass III
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967
by Fagron, Inc
- Reason
- cGMP Deviations: lack of quality assurance at the API manufacturer.
- Published
- November 22, 2017
- 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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