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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Ongoing Historical recordClass II

Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.

by Safecor Health, LLC

Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiated: February 17, 2025
Reported by FDA: March 12, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059.

by Safecor Health, LLC

Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiated: February 17, 2025
Reported by FDA: March 12, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.

by Safecor Health, LLC

Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiated: February 17, 2025
Reported by FDA: March 12, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.

by Safecor Health, LLC

Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiated: February 17, 2025
Reported by FDA: March 12, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Dissolution Specifications
Recall initiated: February 6, 2025
Reported by FDA: March 12, 2025
Distribution: Nationwide within in the USA.

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Drug Recall Completed Historical recordClass II

Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01.

by Turbare Manufacturing

Reason: Lack of Assurance of Sterility: due to a quality control process deviation
Recall initiated: February 18, 2025
Reported by FDA: March 5, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01.

by Wuxi Medical lnstrument Factory Co., Ltd.

Reason: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Recall initiated: February 12, 2025
Reported by FDA: March 5, 2025
Distribution: FL

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Drug 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.
Recall initiated: February 6, 2025
Reported by FDA: March 5, 2025
Distribution: Nationwide in the USA

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Drug 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.
Recall initiated: January 31, 2025
Reported by FDA: February 26, 2025
Distribution: USA Nationwide

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Drug 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.
Recall initiated: January 29, 2025
Reported by FDA: February 26, 2025
Distribution: Nationwide within the U.S

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Drug 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.
Recall initiated: January 29, 2025
Reported by FDA: February 26, 2025
Distribution: Nationwide within the U.S

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Drug 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.
Recall initiated: January 29, 2025
Reported by FDA: February 26, 2025
Distribution: Nationwide within the U.S

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Drug 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.
Recall initiated: January 29, 2025
Reported by FDA: February 26, 2025
Distribution: Nationwide within the U.S

View recall →

Drug 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.
Recall initiated: January 29, 2025
Reported by FDA: February 26, 2025
Distribution: Nationwide within the U.S

View recall →

Drug 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.
Recall initiated: January 29, 2025
Reported by FDA: February 26, 2025
Distribution: Nationwide within the U.S

View recall →

Drug 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.
Recall initiated: January 29, 2025
Reported by FDA: February 26, 2025
Distribution: Nationwide within the U.S

View recall →

Drug 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.
Recall initiated: January 29, 2025
Reported by FDA: February 26, 2025
Distribution: Nationwide within the U.S

View recall →

Drug 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.
Recall initiated: January 29, 2025
Reported by FDA: February 26, 2025
Distribution: Nationwide within the U.S

View recall →

Drug 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.
Recall initiated: January 29, 2025
Reported by FDA: February 26, 2025
Distribution: Nationwide within the U.S

View recall →

Drug 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.
Recall initiated: January 29, 2025
Reported by FDA: February 26, 2025
Distribution: Nationwide within the U.S

View recall →

Data last updated: October 31, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.