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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 1,141–1,160 of 17,898 drug recalls

Drug Recall Terminated Historical recordClass III

Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.

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

Reason
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Recall initiated
March 4, 2025
Reported by FDA
April 9, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4

by Exela Pharma Sciences LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2025
Reported by FDA
April 2, 2025
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109.

by Consumer Product Partners, LLC

Reason
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Recall initiated
March 7, 2025
Reported by FDA
April 2, 2025
Distribution
VA

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Drug Recall Ongoing Historical recordClass I

SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7

by Ascent Consumer Products Inc.

Reason
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Recall initiated
January 28, 2025
Reported by FDA
April 2, 2025
Distribution
Nationwide in the US.

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Drug Recall Ongoing Historical recordClass I

SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4

by Ascent Consumer Products Inc.

Reason
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Recall initiated
January 28, 2025
Reported by FDA
April 2, 2025
Distribution
Nationwide in the US.

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Drug Recall Ongoing Historical recordClass I

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1

by Ascent Consumer Products Inc.

Reason
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Recall initiated
January 28, 2025
Reported by FDA
April 2, 2025
Distribution
Nationwide in the US.

View recall →

Drug Recall Ongoing Historical recordClass II

babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.

by Johnson, S C and Son, Inc

Reason
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Recall initiated
January 8, 2025
Reported by FDA
April 2, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75

by QuVa Pharma, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 6, 2025
Reported by FDA
April 2, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75

by QuVa Pharma, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 6, 2025
Reported by FDA
April 2, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75

by QuVa Pharma, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 6, 2025
Reported by FDA
April 2, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02

by Strides Pharma, Inc.

Reason
Presence of foreign substance: Presence of Benzene.
Recall initiated
March 5, 2025
Reported by FDA
April 2, 2025
Distribution
Nationwide in the U.S

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Drug Recall Ongoing Historical recordClass II

Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02

by Strides Pharma, Inc.

Reason
Presence of foreign substance: Presence of Benzene.
Recall initiated
March 5, 2025
Reported by FDA
April 2, 2025
Distribution
Nationwide in the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.

by A-S Medication Solutions LLC

Reason
Presence of Foreign Tablets/Capsules.
Recall initiated
February 25, 2025
Reported by FDA
April 2, 2025
Distribution
Nationwide in U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.

by Mylan Institutional, Inc.

Reason
Super-Potent Drug: Out of specification potency results were obtained.
Recall initiated
March 7, 2025
Reported by FDA
March 26, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.

by Mylan Institutional, Inc.

Reason
Super-Potent Drug: Out of specification potency results were obtained.
Recall initiated
March 7, 2025
Reported by FDA
March 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30.

by MEDLINE INDUSTRIES, LP - Northfield

Reason
Subpotent Drug
Recall initiated
February 17, 2025
Reported by FDA
March 26, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.

by MEDLINE INDUSTRIES, LP - Northfield

Reason
Subpotent Drug
Recall initiated
February 17, 2025
Reported by FDA
March 26, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30

by Golden State Medical Supply Inc.

Reason
Failed Dissolution Specifications
Recall initiated
March 5, 2025
Reported by FDA
March 26, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box).

by Amgen, Inc.

Reason
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Recall initiated
February 27, 2025
Reported by FDA
March 26, 2025
Distribution
Nationwide in the U.S.A. and Belgium/Luxembourg, Brazil, Chile, Colombia, France/French Guiana, Germany, Ireland, Italy/San Marino, Netherlands, Poland, Spain/Andorra, Sweden, Finland, Switzerland/Liechtenstein, United Kingdom of Great Britain and Northern Ireland, Ireland, Denmark, Canada, Hong Kong, Philippines, Israel, Malaysia, Saudi Arabia, Gibraltar.

View recall →

Drug Recall Ongoing Historical recordClass II

Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box).

by Amgen, Inc.

Reason
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Recall initiated
February 27, 2025
Reported by FDA
March 26, 2025
Distribution
Nationwide in the U.S.A. and Belgium/Luxembourg, Brazil, Chile, Colombia, France/French Guiana, Germany, Ireland, Italy/San Marino, Netherlands, Poland, Spain/Andorra, Sweden, Finland, Switzerland/Liechtenstein, United Kingdom of Great Britain and Northern Ireland, Ireland, Denmark, Canada, Hong Kong, Philippines, Israel, Malaysia, Saudi Arabia, Gibraltar.

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.