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FDA Enforcement Database

Drug Safety & Recalls Center

Access structured drug recall and safety information sourced directly from the U.S. Food & Drug Administration (FDA) OpenFDA Enforcement API. Stay informed on active market withdrawals, manufacturing defect notices, and drug safety advisories.

Last Synchronized
28 minutes ago
Total FDA Recalls
1,170
Active / Ongoing
1,133
Critical (Class I)
63
Data Provenance & Source Transparency: All drug recall records displayed are retrieved directly from the official U.S. FDA OpenFDA Enforcement API. Questo organizes and presents this data for medical education and research without modifying original regulatory facts. Explore OpenFDA API Documentation →
Medical & Legal Disclaimer: The information on this page is compiled for informational and educational reference only and does not constitute medical advice or clinical diagnosis. Never discontinue, start, or substitute any medication without consulting your prescribing doctor or a licensed pharmacist. For urgent health concerns regarding a recalled product, contact your physician immediately or report adverse events to FDA MedWatch.

Latest Critical Safety Updates (Class I)

Recent FDA enforcement reports involving serious health risk classifications

Class I
THYROID
Superpotent Drug
VITRUVIAS THERAPEUTICS INC Sep 23, 2026
Class I
NYSTATIN
Failed Stability Specifications
SUN PHARMACEUTICAL INDUSTRIES... Sep 23, 2026
Class I
SODIUM CHLORIDE
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic mat...
B BRAUN MEDICAL INC Sep 16, 2026
Showing 361–380 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0505-2026

fentaNYL Citrate Injectable Solution

Manufacturer / Recalling Firm: Wells Pharma of Houston LLC
Reason for Recall: cGMP deviations.
FDA Report: May 06, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
Lots / Batch Codes & Expiration Dates
Lot 011226204250063, Exp Date 05/14/2026
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0499-2026

OPTASE

Manufacturer / Recalling Firm: SCOPE HEALTH
Reason for Recall: Lack of Assurance of Sterility
FDA Report: May 06, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot#: 8T98, 9T31, 9T32, Exp. Date: 30/04/26; 2V13, 2V14, 2V15, Exp. Date 30/06/26; 3V35, Exp. Date 31/08/26;3V36, 3V37, Exp. Date 30/09/26; 5V45, 5V46, 9V12, Exp. Date 31/03/27; 1X57, 1X70, 1X84, Exp. Date 31/05/27.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0503-2026

fentaNYL Citrate Injectable Solution

Manufacturer / Recalling Firm: Wells Pharma of Houston LLC
Reason for Recall: cGMP deviations.
FDA Report: May 06, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
120925202022769, Expiration Date 04/09/2026, 123125202022883, Expiration Date 05/05/2026, 123125202022884, Expiration Date 05/05/2026 011226202020057, Expiration Date 05/14/2026, 011226202020058, Expiration Date 05/14/2026, 011626202020110, Expiration Date 05/20/2026 012726202020156, Expiration Date 05/28/2026. 012726202020161, Expiration Date 0...
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0526-2026

ALENDRONATE SODIUM

Manufacturer / Recalling Firm: Hikma Pharmaceuticals USA INC
Reason for Recall: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
FDA Report: May 06, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot # AC2040A, Exp Date: 04/2026
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0492-2026

GENTEAL TEARS

Manufacturer / Recalling Firm: Alcon Research LLC
Reason for Recall: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
FDA Report: May 06, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0504-2026

fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride

Manufacturer / Recalling Firm: Wells Pharma of Houston LLC
Reason for Recall: cGMP deviations.
FDA Report: May 06, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
120125202032701, Exp Date 04/01/2026; 122625202032857, Exp Date 04/25/2026; 122625202032862, Exp Date 04/28/2026, 122625202032863. Exp Date 04/28/2026; 122625202032864, Exp Date 04/28/2026; 122625202032865, Exp Date 04/28/2026, 011226202030062, Exp Date 05/14/2026, 011326202030776, Exp Date 05/15/2026; 011326202030077, Exp Date 05/15/2026,...
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0506-2026

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride

Manufacturer / Recalling Firm: Wells Pharma of Houston LLC
Reason for Recall: cGMP deviations.
FDA Report: May 06, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
Lots / Batch Codes & Expiration Dates
Lot 022326203650432; Exp Date 06/25/2026
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0500-2026

IVIZIA DRY EYE

Manufacturer / Recalling Firm: Thea Pharma, Inc.
Reason for Recall: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
FDA Report: May 06, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
Lot#: 3T36B, Exp. Date October 31, 2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0507-2026

Ketamine Hydrochloride Injectable Solution

Manufacturer / Recalling Firm: Wells Pharma of Houston LLC
Reason for Recall: cGMP deviations.
FDA Report: May 06, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Lots / Batch Codes & Expiration Dates
120925302312764, Exp Date 04/09/2026, 123125302312879 Exp Date, 05/05/2026, 123125302312880, Exp Date 05/05/2026, 010226302310003, Exp Date 05/06/2026, 010626302310007, Exp Date 05/08/2026, 010626302310008, Exp Date 05/08/2026 020426302310243, Exp Date 06/06/2026.
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0501-2026

Similasan

Manufacturer / Recalling Firm: Thea Pharma, Inc.
Reason for Recall: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
FDA Report: May 06, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0484-2026

PANTOPRAZOLE SODIUM

Manufacturer / Recalling Firm: Hetero Labs Limited (Unit V)
Reason for Recall: Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
Batch # FD253967, Exp Date: 06/26/2027
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0495-2026

STERILE WATER

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0497-2026

SODIUM CHLORIDE FOR IRRIGATION

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0521-2026

CLARAVIS

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lots#: 100067507, 100067508, Exp 07/31/2026
Distribution Scope
Nationwide in the USA, Puerto Rico and Virgin Islands
Class II (Moderate Risk)
Drug recall Recall #: D-0498-2026

LACTATED RINGERS IRRIGATION

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Lots / Batch Codes & Expiration Dates
Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.
Distribution Scope
US Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0490-2026

MONSELS SOLUTION

Manufacturer / Recalling Firm: Premier Dental Products Co
Reason for Recall: 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 vi...
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot #: 640911253, Exp Date. 09/14/2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0486-2026

FUROSEMIDE

Manufacturer / Recalling Firm: Leading Pharma, LLC
Reason for Recall: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Lots / Batch Codes & Expiration Dates
Lots# H03125, H03225, H03325, Exp Date: 2027/08
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0496-2026

DEXTROSE

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
Lots / Batch Codes & Expiration Dates
Lot # J5H166, J5H167, Exp Date: 30NOV2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0489-2026

FRESHKOTE LUBRICANT EYEDROPS

Manufacturer / Recalling Firm: Harrow Eye LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Lots / Batch Codes & Expiration Dates
Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0493-2026

OMEGA-3-ACID ETHYL ESTERS

Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Distribution Scope
Nationwide in the USA

FDA Recall Classes & Health Hazard Definitions

Official regulatory classifications defined by the U.S. Food & Drug Administration (21 CFR Part 7)

FDA Health Hazard Classifications
Class I — High Risk Severity

Class I Recall

Regulatory Definition: A situation in which there is a reasonable probability that exposure to a recalled product will cause serious adverse health consequences or death.

Examples: Microbial contamination of sterile injectables, presence of unlabelled severe allergens, toxic impurities, or dosage potency errors.
Class II — Moderate Risk Severity

Class II Recall

Regulatory Definition: A situation in which exposure to a recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote.

Examples: Sub-potent non-life-sustaining tablets, minor dissolution rate variations, or outer carton label misprints.
Class III — Low Risk Severity

Class III Recall

Regulatory Definition: A situation in which exposure to a recalled product is not likely to cause adverse health consequences, but violates FDA packaging or manufacturing regulations.

Examples: Minor packaging flaws, harmless tablet color variances, or minor typographical errors in package inserts.
Enforcement Action Statuses
Ongoing Action

Ongoing Status

The recall action is actively in progress across supply chains, distributors, healthcare facilities, and retail pharmacies nationwide.

Completed / Terminated

Completed & Terminated Status

The FDA has confirmed that all reasonable efforts have been made to remove or correct the product, and the enforcement file is officially closed.

System Notice

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