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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

Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01

by Mallinckrodt Hospital Products Inc.

Reason: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Recall initiated: February 6, 2024
Reported by FDA: February 28, 2024
Distribution: USA nationwide

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Drug Recall Ongoing Historical recordClass II

Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1

by Mallinckrodt Hospital Products Inc.

Reason: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Recall initiated: February 6, 2024
Reported by FDA: February 28, 2024
Distribution: USA nationwide

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Drug Recall Ongoing Historical recordClass II

Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57

by Ascend Laboratories, LLC

Reason: Failed Impurities/Degradation Specification: Out of specification for organic impurities
Recall initiated: January 16, 2024
Reported by FDA: February 28, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.

by Alpha Aromatics

Reason: CGMP Deviations
Recall initiated: January 25, 2024
Reported by FDA: February 28, 2024
Distribution: Product was distributed to two accounts in NC and MI

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Drug Recall Terminated Historical recordClass II

Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.

by Lupin Pharmaceuticals Inc.

Reason: Labeling: Incorrect or Missing Package Insert
Recall initiated: February 5, 2024
Reported by FDA: February 28, 2024
Distribution: OH, IL, NJ

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Drug Recall Ongoing Historical recordClass II

Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20

by Baxter Healthcare Corporation

Reason: Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Recall initiated: January 23, 2024
Reported by FDA: February 28, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

by Neptune Resources, LLC

Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Recall initiated: January 12, 2024
Reported by FDA: February 28, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

by Neptune Resources, LLC

Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Recall initiated: January 12, 2024
Reported by FDA: February 28, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

by Neptune Resources, LLC

Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Recall initiated: January 12, 2024
Reported by FDA: February 28, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

by Bestco LLC

Reason: CGMP Deviations: Potential Glass and Silicone particulates in product
Recall initiated: January 19, 2024
Reported by FDA: February 28, 2024
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

by Bestco LLC

Reason: CGMP Deviations: Potential Glass and Silicone particulates in product
Recall initiated: January 19, 2024
Reported by FDA: February 28, 2024
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

by Bestco LLC

Reason: CGMP Deviations: Potential Glass and Silicone particulates in product
Recall initiated: January 19, 2024
Reported by FDA: February 28, 2024
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

by Bestco LLC

Reason: CGMP Deviations: Potential Glass and Silicone particulates in product
Recall initiated: January 19, 2024
Reported by FDA: February 28, 2024
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass II

CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

by Bestco LLC

Reason: CGMP Deviations: Potential Glass and Silicone particulates in product
Recall initiated: January 19, 2024
Reported by FDA: February 28, 2024
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6

by Amneal Pharmaceuticals of New York, LLC

Reason: Failed Impurities/Degradation Specifications: Out-of-specification test results.
Recall initiated: February 13, 2024
Reported by FDA: February 28, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1

by Apotex Corp.

Reason: CGMP Deviations: potential presence of Burkholderia cepacia complex
Recall initiated: February 9, 2024
Reported by FDA: February 28, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.

by IntegraDose Compounding Services LLC

Reason: Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Recall initiated: January 22, 2024
Reported by FDA: February 21, 2024
Distribution: MN

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Drug Recall Terminated Historical recordClass II

HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Recall initiated: February 9, 2024
Reported by FDA: February 21, 2024
Distribution: The product was distributed nationwide within the United States.

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Drug Recall Ongoing Historical recordClass III

Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58

by Teva Pharmaceuticals USA, Inc

Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Recall initiated: January 25, 2024
Reported by FDA: February 21, 2024
Distribution: nationwide

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Drug Recall Ongoing Historical recordClass III

Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67

by Teva Pharmaceuticals USA, Inc

Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Recall initiated: January 25, 2024
Reported by FDA: February 21, 2024
Distribution: nationwide

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Data last updated: November 1, 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.