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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 3,461–3,480 of 18,075 drug recalls

Drug Recall Terminated Historical recordClass II

Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.

by CIPLA

Reason
Lack of Assurance of Sterility: environmental monitoring failure.
Recall initiated
September 29, 2022
Reported by FDA
October 12, 2022
Distribution
Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass III

Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Recall initiated
September 14, 2022
Reported by FDA
October 12, 2022
Distribution
USA nationwide

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Drug Recall Terminated Historical recordClass III

Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-323-2251, Made in USA, NDC 11429-1010-8

by Woodbine Products Co Inc

Reason
Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.
Recall initiated
August 30, 2022
Reported by FDA
October 12, 2022
Distribution
NC

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Drug Recall Terminated Historical recordClass II

Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)

by Pfizer Inc.

Reason
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Recall initiated
September 27, 2022
Reported by FDA
October 12, 2022
Distribution
Distributed in the United States and Puerto Rico.

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Drug Recall Terminated Historical recordClass I

Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dist. By Antica Farmacista Seattle, WA 98122 UPC 8 47005 00450 9

by Salon Technologies International Inc

Reason
Chemical Contamination: product found to contain benzene
Recall initiated
September 14, 2022
Reported by FDA
October 12, 2022
Distribution
FL and WA only

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Drug Recall Terminated Historical recordClass II

Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 Commodity Circle STE 22-23, Orlando, FL 32819, UPC 6 96952 12904 5

by Salon Technologies International Inc

Reason
GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Recall initiated
September 14, 2022
Reported by FDA
October 12, 2022
Distribution
FL and WA only

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Drug Recall Terminated Historical recordClass III

Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45

by ALMIRALL, LLC

Reason
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Recall initiated
September 16, 2022
Reported by FDA
October 5, 2022
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.

by Akorn, Inc.

Reason
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Recall initiated
September 21, 2022
Reported by FDA
October 5, 2022
Distribution
USA Nationwide and Puerto Rico

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Drug Recall Ongoing Historical recordClass II

Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30

by Akorn, Inc.

Reason
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Recall initiated
September 21, 2022
Reported by FDA
October 5, 2022
Distribution
USA Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01

by Leading Pharma, LLC

Reason
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Recall initiated
August 23, 2022
Reported by FDA
October 5, 2022
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.

by CIPLA

Reason
Lack of Assurance of Sterility
Recall initiated
September 15, 2022
Reported by FDA
October 5, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.

by QuVa Pharma, Inc.

Reason
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Recall initiated
September 20, 2022
Reported by FDA
October 5, 2022
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.

by Novartis Pharmaceuticals Corporation

Reason
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Recall initiated
September 16, 2022
Reported by FDA
October 5, 2022
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A

by Viatris Inc

Reason
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Recall initiated
September 21, 2022
Reported by FDA
October 5, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Recall initiated
June 21, 2022
Reported by FDA
October 5, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Recall initiated
June 21, 2022
Reported by FDA
October 5, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01

by UNICHEM PHARMACEUTICALS USA INC

Reason
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Recall initiated
September 19, 2022
Reported by FDA
September 28, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

by Pfizer Inc.

Reason
Presence of particulate matter
Recall initiated
August 22, 2022
Reported by FDA
September 21, 2022
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02.

by Teva Pharmaceuticals USA Inc

Reason
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
Recall initiated
August 29, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the US.

View recall →

Drug Recall Terminated Historical recordClass II

Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00

by RemedyRePack Inc.

Reason
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Recall initiated
September 15, 2022
Reported by FDA
September 21, 2022
Distribution
Distributed to two direct accounts in PA and AK.

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.

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