FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
NuNaturals Inc
- Product
- Organic Pure Stevia, net wt. 1oz. UPC 7 39223 00204 0. Produ…
- Reason
- Product is Monk Fruit powder but bottle was mis-labeled as Organic Pure Stevia.
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)
by Cipla USA, Inc.
- Reason
- Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
- Published
- July 30, 2025
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
- Published
- July 30, 2025
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass III
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
by Imprimis NJOF, LLC
- Reason
- Sub-Potent Drug: Subpotent assay results during stability testing.
- Published
- July 30, 2025
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
by Imprimis NJOF, LLC
- Reason
- Sub-Potent Drug: Subpotent assay results during stability testing.
- Published
- July 30, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224
by A.P. Deauville, LLC
- Reason
- CGMP Deviations
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194
by A.P. Deauville, LLC
- Reason
- CGMP Deviations
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313
by A.P. Deauville, LLC
- Reason
- CGMP Deviations
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18
by Ascend Laboratories, LLC
- Reason
- CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
by Ascend Laboratories, LLC
- Reason
- CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
by Lupin Pharmaceuticals Inc.
- Reason
- Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
by Dr. Reddy's Laboratories, Inc.
- Reason
- Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug: Assay below the approved specification
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug: Assay below the approved specification
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug: Assay below the approved specification
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug: Assay below the approved specification
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-15
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug: Assay below the approved specification
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug: Assay below the approved specification
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug: Assay below the approved specification
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01
by Qualgen, LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
- Published
- July 23, 2025
- 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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