FDA Recall
Terminated
Historical recordClass II
Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30
by Hetero Labs Limited Unit V
- Reason
- Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Swire Coca Cola USA
- Product
- Caffeine-Free Barq s Root Beer 12 Pack, 12 oz cans
- Reason
- Recalling Caffeine-Free Barq s Root Beer 12 Pack due to mislabeling.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Brett Anthony Foods
- Product
- Gotham Greens Classic Pesto 6.5 oz. plastic cup, 12 cups pe…
- Reason
- Ingredient declaration does not match principal display panel. Product is classic pesto with basil, parmigiano, and pine nuts. Ingredients listed for vegan pesto without parmigiano (milk). Principal display panel correctly identifies product as classic pesto and lists basil, parmigiano, and pine nuts.
- Published
- October 3, 2018
- Distribution
- The product was sold by Whole Foods Mark…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Swanson Health Products, Inc
- Product
- Swanson Ultra, Himalayan Crystal Salt, #SWU403, Net Wt. 35.2…
- Reason
- Himalayan Crystal Salt may contain metal wire pieces.
- Published
- October 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Zakah Life LLC
- Product
- Top Shelf White Maeng Da Premium Kratom, Zakah Life Dietary…
- Reason
- The firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Also, based on FDA sample positive sample results, the red and green strains are potentially contaminated with Salmonella.
- Published
- October 3, 2018
- Distribution
- Distributed to consumers and retailers i…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Zakah Life LLC
- Product
- Super Green Maeng Da Premium Kratom, Zakah Life Dietary Supp…
- Reason
- The firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Also, based on FDA sample positive sample results, the red and green strains are potentially contaminated with Salmonella.
- Published
- October 3, 2018
- Distribution
- Distributed to consumers and retailers i…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Zakah Life LLC
- Product
- Powerful Red Vein Bali Premium Kratom, Zakah Life Dietary Su…
- Reason
- The firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Also, based on FDA sample positive sample results, the red and green strains are potentially contaminated with Salmonella.
- Published
- October 3, 2018
- Distribution
- Distributed to consumers and retailers i…
View recall →
FDA Recall
Terminated
Historical recordClass III
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01
by LUPIN SOMERSET
- Reason
- Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
by InvaGen Pharmaceuticals, Inc.
- Reason
- Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30
by Torrent Pharma Inc.
- Reason
- Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7042-7
by Beaumont Bio-med, Inc.
- Reason
- CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7
by Beaumont Bio-med, Inc.
- Reason
- CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7011-7
by Beaumont Bio-med, Inc.
- Reason
- CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7041-7
by Beaumont Bio-med, Inc.
- Reason
- CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7022-7
by Beaumont Bio-med, Inc.
- Reason
- CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7014-7
by Beaumont Bio-med, Inc.
- Reason
- CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- Published
- September 26, 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.
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