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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 401–420 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass II

Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.

by Hikma Pharmaceuticals USA INC

Reason
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Recall initiated
April 7, 2026
Reported by FDA
May 6, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass III

Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950

by Water-Jel Technologies, LLC

Reason
Failed PH Specifications
Recall initiated
April 7, 2026
Reported by FDA
May 6, 2026
Distribution
Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

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 →

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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