FDA Recall
TerminatedTerminated: August 19, 2019Historical recordClass II
Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Cross Contamination With Other Products:
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 26, 2020Historical recordClass III
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.
by Baxter Healthcare Corporation
- Reason
- Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 5, 2021Historical recordClass II
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
by Hetero Labs Limited Unit V
- Reason
- Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 9, 2020Historical 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
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FDA Recall
TerminatedTerminated: September 9, 2020Historical 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
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FDA Recall
TerminatedTerminated: September 9, 2020Historical 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
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FDA Recall
TerminatedTerminated: September 9, 2020Historical 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
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FDA Recall
OngoingHistorical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 13, 2018Historical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 4, 2019Historical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 5, 2019Historical recordClass II
Confidence Inc./Confidence U.S.A. Inc.
- Product
- FP0392, For-Men-10, All Natural Formula to Overall Men's Hea…
- Reason
- Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG), Triacetin, FD&C Yellow #6 (Sunset Yellow FCF), FD&C Red #40 (Allura Red AC), FD&C Blue #1 (Aluminum Lake).
- Published
- October 3, 2018
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 5, 2019Historical recordClass III
Confidence Inc./Confidence U.S.A. Inc.
- Product
- FP0191, Confidence, Bone-Lock WITHGENISTEIN AND CHLOROPHYLL,…
- Reason
- Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG).
- Published
- October 3, 2018
- Distribution
- Multiple states
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FDA Recall
TerminatedTerminated: October 14, 2022Historical 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
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FDA Recall
TerminatedTerminated: October 22, 2020Historical 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
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FDA Recall
TerminatedTerminated: September 4, 2020Historical 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
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FDA Recall
TerminatedTerminated: September 16, 2022Historical 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
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FDA Recall
TerminatedTerminated: September 16, 2022Historical 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
TerminatedTerminated: September 16, 2022Historical 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
TerminatedTerminated: September 16, 2022Historical 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
TerminatedTerminated: September 16, 2022Historical 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 →
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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