FDA Recall
Terminated
Historical recordClass I
Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3.
by Epic Products, LLC
- Reason
- Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
by Breckenridge Pharmaceutical, Inc.
- Reason
- Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01
by Sandoz Inc
- Reason
- Cross Contamination with Other Products
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
by Sandoz Inc
- Reason
- Cross Contamination with Other Products
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00
by Sandoz Inc
- Reason
- Cross Contamination with Other Products
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00
by Sandoz Inc
- Reason
- Cross Contamination with Other Products
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01
by Sandoz Inc
- Reason
- Cross Contamination with Other Products
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540
by Sandoz Inc
- Reason
- Cross Contamination with Other Products
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
by Kadesh International
- Reason
- Non-Sterility: Product manufactured under non-sterile production conditions.
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
by Zero Xtreme USA
- Reason
- Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02
by Silver Star Brands
- Reason
- CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02
by Silver Star Brands
- Reason
- CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-151-59
by Silver Star Brands
- Reason
- Microbial Contamination of Non-Sterile Product
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-275-02
by Silver Star Brands
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02
by Silver Star Brands
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA
by Medline Industries Inc
- Reason
- Microbial Contamination of Non-Sterile Product
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
by Qualgen, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 14, 2018
- 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.