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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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Showing 3,241–3,260 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

by Aurolife Pharma, LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
December 16, 2022
Reported by FDA
December 28, 2022
Distribution
Nationwide in the USA and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Presence of foreign substance
Recall initiated
December 1, 2022
Reported by FDA
December 28, 2022
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26

by Camber Pharmaceuticals, Inc

Reason
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Recall initiated
December 6, 2022
Reported by FDA
December 21, 2022
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass I

Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.

by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

Reason
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Recall initiated
December 1, 2022
Reported by FDA
December 21, 2022
Distribution
BayCare Health System hospitals in FL

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Drug Recall Terminated Historical recordClass II

Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.

by Atlantic Management Resources Ltd.

Reason
cGMP Deviations
Recall initiated
December 12, 2022
Reported by FDA
December 21, 2022
Distribution
Nationwide and Australia

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Drug Recall Terminated Historical recordClass II

ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.

by Atlantic Management Resources Ltd.

Reason
cGMP Deviations
Recall initiated
December 12, 2022
Reported by FDA
December 21, 2022
Distribution
Nationwide and Australia

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Drug Recall Terminated Historical recordClass II

Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.

by Atlantic Management Resources Ltd.

Reason
cGMP Deviations
Recall initiated
December 12, 2022
Reported by FDA
December 21, 2022
Distribution
Nationwide and Australia

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Drug Recall Terminated Historical recordClass II

Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.

by Atlantic Management Resources Ltd.

Reason
cGMP Deviations
Recall initiated
December 12, 2022
Reported by FDA
December 21, 2022
Distribution
Nationwide and Australia

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Drug Recall Terminated Historical recordClass I

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.

by Exela Pharma Sciences LLC

Reason
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Recall initiated
November 28, 2022
Reported by FDA
December 21, 2022
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass I

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.

by Exela Pharma Sciences LLC

Reason
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Recall initiated
November 28, 2022
Reported by FDA
December 21, 2022
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01

by OurPharma LLC

Reason
Underfilled units.
Recall initiated
November 29, 2022
Reported by FDA
December 21, 2022
Distribution
MO

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Drug Recall Terminated Historical recordClass II

Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00.

by RemedyRePack Inc.

Reason
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Recall initiated
December 5, 2022
Reported by FDA
December 14, 2022
Distribution
Product was distributed to two different customers in MI.

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Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862

by B. Braun Medical, Inc.

Reason
Lack of sterility assurance: Bags have the potential to leak.
Recall initiated
November 25, 2022
Reported by FDA
December 14, 2022
Distribution
FL, NJ, PA

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Drug Recall Ongoing Historical recordClass II

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10

by Fresenius Medical Care Holdings, Inc.

Reason
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Recall initiated
November 22, 2022
Reported by FDA
December 14, 2022
Distribution
Product was distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass III

Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60

by Acella Pharmaceuticals, LLC

Reason
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Recall initiated
November 14, 2022
Reported by FDA
December 7, 2022
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass III

Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications
Recall initiated
November 21, 2022
Reported by FDA
December 7, 2022
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01

by Heritage Pharmaceuticals Inc

Reason
Subpotent Drug
Recall initiated
November 23, 2022
Reported by FDA
December 7, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Recall initiated
November 16, 2022
Reported by FDA
December 7, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

by Acella Pharmaceuticals, LLC

Reason
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Recall initiated
November 14, 2022
Reported by FDA
November 30, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass III

Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

by Acella Pharmaceuticals, LLC

Reason
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Recall initiated
November 14, 2022
Reported by FDA
November 30, 2022
Distribution
Nationwide in the USA.

View recall →

Data last updated:

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.