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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 261–280 of 17,898 drug recalls

Drug Recall Ongoing 2026 recordClass II

Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11

by Thea Pharma, Inc.

Reason
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Recall initiated
April 23, 2026
Reported by FDA
May 6, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11

by Thea Pharma, Inc.

Reason
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Recall initiated
April 23, 2026
Reported by FDA
May 6, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.

by SCOPE HEALTH

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2026
Reported by FDA
May 6, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass III

Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01

by American Regent, Inc.

Reason
Labeling: Missing Label
Recall initiated
April 16, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.

by Alcon Research LLC

Reason
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Recall initiated
April 21, 2026
Reported by FDA
May 6, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01

by Alcon Research LLC

Reason
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Recall initiated
April 21, 2026
Reported by FDA
May 6, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

by Teva Pharmaceuticals USA, Inc

Reason
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Recall initiated
April 6, 2026
Reported by FDA
April 29, 2026
Distribution
Nationwide in the USA, Puerto Rico and Virgin Islands

View recall →

Drug Recall Ongoing 2026 recordClass II

LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.

by B BRAUN MEDICAL INC

Reason
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Recall initiated
April 2, 2026
Reported by FDA
April 29, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.

by B BRAUN MEDICAL INC

Reason
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Recall initiated
April 2, 2026
Reported by FDA
April 29, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.

by B BRAUN MEDICAL INC

Reason
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Recall initiated
April 2, 2026
Reported by FDA
April 29, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.

by B BRAUN MEDICAL INC

Reason
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Recall initiated
April 2, 2026
Reported by FDA
April 29, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass III

Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.

by Premier Dental Products Co

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Recall initiated
April 14, 2026
Reported by FDA
April 29, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.

by Harrow Eye LLC

Reason
Lack of Assurance of Sterility
Recall initiated
April 17, 2026
Reported by FDA
April 29, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01

by Leading Pharma, LLC

Reason
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Recall initiated
March 20, 2026
Reported by FDA
April 29, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10

by Hetero Labs Limited (Unit V)

Reason
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Recall initiated
March 26, 2026
Reported by FDA
April 29, 2026
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing 2026 recordClass II

Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06

by The Harvard Drug Group LLC

Reason
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Recall initiated
April 9, 2026
Reported by FDA
April 29, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)

by Huons Co., Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
April 2, 2026
Reported by FDA
April 22, 2026
Distribution
USA Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.

by Huons Co., Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
April 2, 2026
Reported by FDA
April 22, 2026
Distribution
USA Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)

by Huons Co., Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
April 2, 2026
Reported by FDA
April 22, 2026
Distribution
USA Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)

by Huons Co., Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
April 2, 2026
Reported by FDA
April 22, 2026
Distribution
USA Nationwide.

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.