FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
First Source, LLC
- Product
- (Canada) Circle K Favourites Dark Chocolate Covered Almonds…
- Reason
- Chocolate products contain undeclared milk
- Published
- December 20, 2017
- Distribution
- AR, AZ, CA, CO, FL, GA, IL, KY, LA, MA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
First Source, LLC
- Product
- (Canada) - Favourites Dark Chocolate Covered Almonds 113 gra…
- Reason
- Chocolate products contain undeclared milk
- Published
- December 20, 2017
- Distribution
- AR, AZ, CA, CO, FL, GA, IL, KY, LA, MA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
First Source, LLC
- Product
- Tops Dark Chocolate Coffee Beans Net Wt 12 OZ (340g) UPC: 0…
- Reason
- Chocolate products contain undeclared milk
- Published
- December 20, 2017
- Distribution
- AR, AZ, CA, CO, FL, GA, IL, KY, LA, MA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
First Source, LLC
- Product
- Wegmans Dark Chocolate Strawberries 13.5oz (383g) tub, UPC:…
- Reason
- Chocolate products contain undeclared milk
- Published
- December 20, 2017
- Distribution
- AR, AZ, CA, CO, FL, GA, IL, KY, LA, MA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
First Source, LLC
- Product
- Wegmans Dark Chocolate Cherry Infused Cranberries 12 OZ (340…
- Reason
- Chocolate products contain undeclared milk
- Published
- December 20, 2017
- Distribution
- AR, AZ, CA, CO, FL, GA, IL, KY, LA, MA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
First Source, LLC
- Product
- (1)Wegmans Dark Chocolate Almonds with Sea Salt and Turbinad…
- Reason
- Chocolate products contain undeclared milk
- Published
- December 20, 2017
- Distribution
- AR, AZ, CA, CO, FL, GA, IL, KY, LA, MA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
First Source, LLC
- Product
- Dark Chocolate Almonds packaged under the brand names: (1)…
- Reason
- Chocolate products contain undeclared milk
- Published
- December 20, 2017
- Distribution
- AR, AZ, CA, CO, FL, GA, IL, KY, LA, MA,…
View recall →
FDA Recall
Terminated
Historical recordClass I
grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distributed by Grande X Ontario, CA 91745, UPC 640793555440
by Gadget Island, Inc
- Reason
- Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
- Published
- December 13, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
by Gadget Island, Inc
- Reason
- Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
- Published
- December 13, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
by Gadget Island, Inc
- Reason
- Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
- Published
- December 13, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
by Gadget Island, Inc
- Reason
- Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
- Published
- December 13, 2017
- Distribution
- Nationwide
View recall →
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
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Leclerc Foods USA
- Product
- Fit & Active Chocolatey Chip Protein Meal Bars; UPC: 41498 1…
- Reason
- Firm received reports of flexible pieces of yellow plastic found in Fit & Active Chocolatey Chip Protein Meal Bars.
- Published
- December 13, 2017
- Distribution
- Connecticut, Delaware, Florida, Georgia,…
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
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 →
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.