FDA Recall
Terminated
Historical recordClass I
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
by International Laboratories, Inc.
- Reason
- Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
- Published
- December 13, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Health Matters America Inc.
- Product
- Organic traditions brand DARK CHOCOLATE ALMONDS 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 ALMONDS, NET WT. 3.5…
- 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 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…
View recall →
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…
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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
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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
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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
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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
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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
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
FANTE, Inc., dba Casa Sanchez Foods
- Product
- Casa Sanchez Foods, Spicy Guacamole; Net Wt. 9 oz.. (255 g)…
- Reason
- FDA found Listeria monocytogenes in surveillance sample of guacamole.
- Published
- December 6, 2017
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
FANTE, Inc., dba Casa Sanchez Foods
- Product
- Casa Sanchez Foods, Real Guacamole; Net Wt. 9 oz.. (255 g),…
- Reason
- FDA found Listeria monocytogenes in surveillance sample of guacamole.
- Published
- December 6, 2017
- Distribution
- U.S. distribution to the following: CA,…
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 II
Ventura Foods Llc
- Product
- SunGlow, Unsalted European Style Butter Blend Margarine (169…
- Reason
- SunGlow contains undeclared soy lecithin.
- Published
- November 29, 2017
- Distribution
- Multiple states
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
🇺🇸 United States
Terminated
Historical recordClass II
GKI Foods, LLC
- Product
- Dark Chocolate Pretzel Nibs, 15 lbs.
- Reason
- GKI Foods of Brighton, Michigan is voluntarily recalling multiple dark chocolate products because they may contain an undeclared milk allergen.
- Published
- November 29, 2017
- Distribution
- Domestic: MI, IN, IL, FL, TX, CA., NV, O…
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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