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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
2 weeks ago
Total FDA Recalls
999
Active / Ongoing
962
Critical (Class I)
45
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
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinib...
Blaine Labs Inc Jul 08, 2026
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Ste...
CareFusion 213, LLC Jul 01, 2026
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides.
CareFusion 213, LLC Jul 01, 2026
Showing 181–200 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0514-2026

DULOXETINE

Manufacturer / Recalling Firm: Ajanta Pharma Ltd.
Reason for Recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India
Lots / Batch Codes & Expiration Dates
Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.
Distribution Scope
Nationwide within U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0517-2026

PURPREP

Manufacturer / Recalling Firm: CareFusion 213, LLC
Reason for Recall: Lack of assurance of Sterility: potential product contamination
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
Lots / Batch Codes & Expiration Dates
Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0518-2026

PURPREP

Manufacturer / Recalling Firm: CareFusion 213, LLC
Reason for Recall: Lack of assurance of Sterility: potential product contamination
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41
Lots / Batch Codes & Expiration Dates
Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0524-2026

TPN bag

Manufacturer / Recalling Firm: Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
Reason for Recall: Incorrect Product Formulation: product did not contain insulin as listed in the label.
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
Lots / Batch Codes & Expiration Dates
Lot #: 11-4909703-0-1, Exp 12/28/2025
Distribution Scope
CA
Class II (Moderate Risk)
Drug recall Recall #: D-0508-2026

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, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
Lots / Batch Codes & Expiration Dates
Lot 020226202150202, Exp Date 05/05/2026.
Distribution Scope
U.S. Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0494-2026

LEVOCARNITINE

Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Labeling: Missing Label
FDA Report: May 06, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0502-2026

Phenylephrine 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
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Lots / Batch Codes & Expiration Dates
120325122032719, Exp Date 04/03/2026, 120425122032734 Exp Date 04/04/2026, 120425122032735, Exp Date 04/04/2026, 120925122032781, Exp Date 04/10/2026, 010626122030010, Exp Date, 05/08/2026, 010626122030009, Exp Date 05/08/2026, 010826122030031, Exp Date 05/13/2026, 010826122030032, Exp Date 05/13/2026, 011326122030072, Exp Date 05/15/2026,...
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0491-2026

SYSTANE

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
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
Lots / Batch Codes & Expiration Dates
Lot#: 9T21, Exp Date: 4/30/2026; Lot# 1U63, 2U47, Exp Date: 5/31/2026; Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027; Lot# 9V55, 8V58, 9V39, 9V97, Exp Date: 2/28/2027; Lot# 1W39, 1W40, Exp Date: 3/31/2027; Lot# 1X76, Exp Date: 4/30/2027.
Distribution Scope
Nationwide within the United States
Class III (Low Risk)
Drug recall Recall #: D-0509-2026

Lidocaine Wound Gel

Manufacturer / Recalling Firm: Water-Jel Technologies, LLC
Reason for Recall: Failed PH Specifications
FDA Report: May 06, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
Lots: A5014, A5018, A5019
Distribution Scope
Nationwide in the USA
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.

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

Confirm Action