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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 I

ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3).

by Exela Pharma Sciences LLC

Reason: Presence of Particulate Matter: Silicone
Recall initiated: October 18, 2023
Reported by FDA: November 29, 2023
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass I

Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4).

by Exela Pharma Sciences LLC

Reason: Presence of Particulate Matter: Silicone
Recall initiated: October 18, 2023
Reported by FDA: November 29, 2023
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass I

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.

by Exela Pharma Sciences LLC

Reason: Presence of Particulate Matter: Silicone
Recall initiated: October 18, 2023
Reported by FDA: November 29, 2023
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 19312 USA NDC:70726-0303-1 (carton) and 70726-0303-2 (bottle)

by ITF PHARMA INC

Reason: Failed Viscosity Specifications: Out-of-specification test results for viscosity
Recall initiated: October 20, 2023
Reported by FDA: November 29, 2023
Distribution: Distributed to one distributor in TN who may have further distributed.

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Drug Recall Terminated Historical recordClass III

Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.

by NCS Healthcare of Kentucky Inc

Reason: Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Recall initiated: October 27, 2023
Reported by FDA: November 29, 2023
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass III

Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.

by NCS Healthcare of Kentucky Inc

Reason: Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Recall initiated: October 27, 2023
Reported by FDA: November 29, 2023
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass III

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,

by Glenmark Pharmaceuticals Inc., USA

Reason: Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Recall initiated: October 23, 2023
Reported by FDA: November 29, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03

by Integrity Bio-Chemicals LLC

Reason: CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Recall initiated: October 18, 2023
Reported by FDA: November 29, 2023
Distribution: Distributed to one distributor in OK with possibility of further distribution

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Drug Recall Terminated Historical recordClass II

Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03

by Integrity Bio-Chemicals LLC

Reason: CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Recall initiated: October 18, 2023
Reported by FDA: November 29, 2023
Distribution: Distributed to one distributor in OK with possibility of further distribution

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Drug Recall Terminated Historical recordClass II

Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA NDC: 77512-044-03

by Integrity Bio-Chemicals LLC

Reason: CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Recall initiated: October 18, 2023
Reported by FDA: November 29, 2023
Distribution: Distributed to one distributor in OK with possibility of further distribution

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Drug Recall Terminated Historical recordClass I

Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94

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

Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recall initiated: October 31, 2023
Reported by FDA: November 29, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass I

Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.

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

Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recall initiated: October 31, 2023
Reported by FDA: November 29, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.

by Family Medical Supply Inc

Reason: cGMP Deviations
Recall initiated: November 9, 2023
Reported by FDA: November 22, 2023
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9

by Omega & Delta Co., Inc.

Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Recall initiated: October 20, 2023
Reported by FDA: November 22, 2023
Distribution: Distributed in Puerto Rico only.

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Drug Recall Ongoing Historical recordClass II

DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4

by Omega & Delta Co., Inc.

Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Recall initiated: October 20, 2023
Reported by FDA: November 22, 2023
Distribution: Distributed in Puerto Rico only.

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Drug Recall Ongoing Historical recordClass II

DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4

by Omega & Delta Co., Inc.

Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Recall initiated: October 20, 2023
Reported by FDA: November 22, 2023
Distribution: Distributed in Puerto Rico only.

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Drug Recall Terminated Historical recordClass I

2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11

by Pfizer Inc.

Reason: Presence of Particulate Matter: identified as glass.
Recall initiated: October 2, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.

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Drug Recall Terminated Historical recordClass I

1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11

by Pfizer Inc.

Reason: Presence of Particulate Matter: identified as glass.
Recall initiated: October 2, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.

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Drug Recall Terminated Historical recordClass I

4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24

by Pfizer Inc.

Reason: Presence of Particulate Matter: identified as glass.
Recall initiated: October 2, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.

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Drug Recall Terminated Historical recordClass III

V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935

by Grato Holdings, Inc.

Reason: Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Recall initiated: October 30, 2023
Reported by FDA: November 15, 2023
Distribution: Distributed to one direct account in Florida with possible further distribution out of state.

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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.