FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426
by Provepharm Inc.
- Reason
- Presence of Particulate Matter.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90
by AvKARE
- Reason
- Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Feel Good Foods Inc
- Product
- Feel Good Foods; Three Cheese Mac & Cheese Bites; NET WT 8oz…
- Reason
- Foreign object (metal pieces).
- Published
- February 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
by AvKARE
- Reason
- Out of Specification for Dissolution
- Published
- February 19, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, Inc.
- Product
- Front Panel: Shirakiku brand, CURVEE PUFFS CORN PUFF SNACK,…
- Reason
- Undeclared allergen (Milk) in Shirakiku brand Curvee Puffs Corn Puff Snack
- Published
- February 19, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, Inc.
- Product
- Front Panel: Shirakiku brand, CURVEE PUFFS CORN PUFF SNACK,…
- Reason
- Undeclared allergen (Milk) in Shirakiku brand Curvee Puffs Corn Puff Snack
- Published
- February 19, 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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