FDA Recall
Completed
Historical recordClass II
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
by Padagis US LLC
- Reason
- Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
- Published
- March 5, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
V Chocolates, Inc
- Product
- Assorted Chocolate Caramels with kosher sea salt, Net Weight…
- Reason
- Small pieces of plastic broken tray in the product.
- Published
- March 5, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nestle-USA, Inc. (Corporate Office)
- Product
- Gerber Snacks for Baby Soothe 'n' Chew TEETHING STICKS Banan…
- Reason
- Firm received complaints of infant choking.
- Published
- March 5, 2025
- Distribution
- The products were shipped to distributio…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nestle-USA, Inc. (Corporate Office)
- Product
- Gerber Snacks for Baby Soothe 'n' Chew TEETHING STICKS Straw…
- Reason
- Firm received complaints of infant choking.
- Published
- March 5, 2025
- Distribution
- The products were shipped to distributio…
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FDA Recall
Ongoing
Historical recordClass I
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.
by Alvogen, Inc
- Reason
- Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
- Published
- February 26, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
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
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FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
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
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FDA Recall
Ongoing
Historical recordClass II
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
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
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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
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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
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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 →
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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