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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
10 hours 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 941–960 of 1,170 factual FDA recall reports
Class I (High Risk)
Drug recall Recall #: D-0628-2025

SODIUM CHLORIDE

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Presence of Particulate Matter.
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Lots / Batch Codes & Expiration Dates
Lot #: V3K770, Exp 1/31/2026
Distribution Scope
U.S.A. Nationwide
Class I (High Risk)
Drug recall Recall #: D-0613-2025

PeriGiene

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
Lots / Batch Codes & Expiration Dates
Lot #: 31013A, Exp. Date 11/2025; 40345A, 40355A, Exp. Date 4/2026; 40571A, 40580A, Exp. Date 6/2026; 40587A, 40591A, Exp. Date 7/2026; 40870.1, 40877.1, Exp. Date 10/2026; 41093A, Exp. Date 12/2026; 50072A, 50079A, Exp. Date 1/2027
Distribution Scope
Nationwide within the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0608-2025

Semaglutide

Manufacturer / Recalling Firm: Boothwyn Pharmacy LLC
Reason for Recall: Subpotent Drug
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Lots / Batch Codes & Expiration Dates
03202025@9 BUD 07/18/2025
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0603-2025

INCONTROL ALCOHOL

Manufacturer / Recalling Firm: MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
FDA Report: Sep 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.
Lots / Batch Codes & Expiration Dates
61224080041
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0605-2025

ALCOHOL

Manufacturer / Recalling Firm: MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
FDA Report: Sep 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2.
Lots / Batch Codes & Expiration Dates
61224070083
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0598-2025

SUCRALFATE

Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity charac...
FDA Report: Sep 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
Lots / Batch Codes & Expiration Dates
Lot 1015038, Exp Date 07/31/2025, Lot 1015898, Exp Date 09/30/2025; Lot 1016873, Exp Date 10/31/2025 and Lot 1023398, Exp Date 07/31/2026.
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0599-2025

LISDEXAMFETAMINE DIMESYLATE

Manufacturer / Recalling Firm: Lannett Company Inc.
Reason for Recall: Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
FDA Report: Sep 03, 2025 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
Lots / Batch Codes & Expiration Dates
Lot #: 25280726A, Exp. Date 03/2027
Distribution Scope
Nationwide within the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0600-2025

MEDLINE ALCOHOL PREP

Manufacturer / Recalling Firm: MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
FDA Report: Sep 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
61224040057
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0596-2025

ACETAMINOPHEN

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: Discoloration
FDA Report: Sep 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.
Lots / Batch Codes & Expiration Dates
Lot #: 24A27G66, Exp 12/31/2025
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0602-2025

WALMART

Manufacturer / Recalling Firm: MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
FDA Report: Sep 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.
Lots / Batch Codes & Expiration Dates
61224070073
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0597-2025

ENOXAPARIN SODIUM

Manufacturer / Recalling Firm: Cardinal Health Inc.
Reason for Recall: Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
FDA Report: Sep 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package - NDC 55154-3543-5, Inner label - NDC 0781-3238-01
Lots / Batch Codes & Expiration Dates
Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A
Distribution Scope
KS
Class II (Moderate Risk)
Drug recall Recall #: D-0601-2025

CURAD ALCOHOL PREP PADS

Manufacturer / Recalling Firm: MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
FDA Report: Sep 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
61224050002
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0604-2025

GOOD NEIGHBOR PHARMACY ALCOHOL ANTISEPTIC SKIN CLEANSER

Manufacturer / Recalling Firm: MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
FDA Report: Sep 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.
Lots / Batch Codes & Expiration Dates
61224070074
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0589-2025

BZK Antiseptic Towelette

Manufacturer / Recalling Firm: Taizhou Kangping Medical Science And Technology Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility.
FDA Report: Aug 27, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01
Lots / Batch Codes & Expiration Dates
Lot Numbers: 220583459, 230553459, 232743459, 110523, 031524, 052224, 247793459
Distribution Scope
NY
Class II (Moderate Risk)
Drug recall Recall #: D-0594-2025

CARVEDILOL

Manufacturer / Recalling Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Reason for Recall: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
FDA Report: Aug 27, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
Lots / Batch Codes & Expiration Dates
Lot #: T05693, Exp. Date 03/2026
Distribution Scope
Product was distributed nationwide within the United States.
Class II (Moderate Risk)
Drug recall Recall #: D-0595-2025

TAVABOROLE

Manufacturer / Recalling Firm: VIONA PHARMACEUTICALS INC
Reason for Recall: Discoloration
FDA Report: Aug 27, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04
Lots / Batch Codes & Expiration Dates
Lot #: T401968
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0591-2025

SODIUM BICARBONATE

Manufacturer / Recalling Firm: PFIZER INC
Reason for Recall: Lack of Assurance of Sterility.
FDA Report: Aug 27, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
Lots / Batch Codes & Expiration Dates
Lot #: LH2671, Exp. 11/30/2026
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0590-2025

Vial Label: Epinephrine Injection

Manufacturer / Recalling Firm: PFIZER INC
Reason for Recall: Lack of Assurance of Sterility.
FDA Report: Aug 27, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
Lots / Batch Codes & Expiration Dates
Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026
Distribution Scope
U.S. Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0593-2025

ALBUTEROL SULFATE

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
FDA Report: Aug 27, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
Lots / Batch Codes & Expiration Dates
Lot#: 4IB0519, Exp. 04/30/2026
Distribution Scope
U.S. Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0592-2025

Sensodyne PRONAMEL

Manufacturer / Recalling Firm: Haleon US Holdings LLC
Reason for Recall: Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
FDA Report: Aug 27, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2
Lots / Batch Codes & Expiration Dates
Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027
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

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