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 →
FDA Recall
Terminated
Historical recordClass II
Sinus 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 58066-7013-7
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
Skin Irritation & Itch 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 58066-7002-7
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
Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153
by Dr. Reddy's Laboratories, Inc.
- Reason
- Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
by Baxter Healthcare Corporation
- Reason
- cGMP Deviation
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
by QuVa Pharma, Inc.
- Reason
- Subpotent Drug: Product may not have the active ingredient present in the bag.
- Published
- September 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01.
by ACCORD HEALTHCARE, INC.
- Reason
- Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02
by Hellolife
- Reason
- Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-025-02
by Hellolife
- Reason
- Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-015-02
by Hellolife
- Reason
- Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02
by Hellolife
- Reason
- Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
- Published
- September 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
- Published
- September 19, 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.