FDA Recall
Terminated
Historical recordClass III
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.
by X-Gen Pharmaceuticals Inc.
- Reason
- Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
- Published
- April 17, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.
by Auro Pharmacies Inc. DBA Central Drugs
- Reason
- Failed pH Specification: product does not meet pH label claim.
- Published
- April 17, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Theo Chocolate Inc
- Product
- Sea Salt 70% Dark Chocolate 3 oz. bars, wrapped in foil and…
- Reason
- Theo Chocolate Sea Salt 70% Dark Chocolate Bar is recalled due to undeclared milk.
- Published
- April 17, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GOOD KARMA FOODS INC
- Product
- PL Trader Joe Natural Creamer - Vanilla 12/32oz, Plastic bot…
- Reason
- Product was recalled due to undeclared milk. The Contains statement does not list milk as an ingredient.
- Published
- April 17, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Merical, LLC
- Product
- Walgreens Probiotic 12.5 Billion Active Cultures, 30 capsule…
- Reason
- Incorrect probiotic strain used in formulation which did not match product labeling.
- Published
- April 17, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Label mix-up
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Label mix-up
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
by Johnson Matthey Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Better Made Snack Foods Inc.
- Product
- Better Made Snack Foods Family Size $3.99 Original Potato Ch…
- Reason
- Undeclared milk
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Century Snacks LLC
- Product
- Snak Club Honey Bliss Nut Mix: Honey Butter Flavored Almond…
- Reason
- Internal label review discovered that Honey Butter Seasoning contains MILK allergen but allergen was not declared on finished packaging but rather was listed as Natural Flavors.
- Published
- April 10, 2019
- Distribution
- U.S. distribution to the following: Alab…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fungi Perfecti LLC
- Product
- Host Defense MycoBotanicals Blood Sugar, dietary supplement,…
- Reason
- Host Defense MycoBotanicals Blood Sugar, 60 ct. bottles, is recalled due to undeclared wheat.
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0
by Ata International Inc
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
- Published
- April 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49
by Ecolab Inc
- Reason
- Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
- Published
- April 3, 2019
- 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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