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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
8 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 41–60 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0805-2026

VANCOMYCIN HYDROCHLORIDE

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.
Lots / Batch Codes & Expiration Dates
Lot # NC188678, Exp Date: 12/1/2026; Lot # NC188814, Exp Date: 12/5/2026; Lot # NC188944, Exp Date: 12/8/2026; Lot # NC193610, Exp Date: 4/21/2027, Lot # NC193665, Exp Date: 4/23/2027.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0818-2026

CLINDAMYCIN PHOSPHATE

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-995-24.
Lots / Batch Codes & Expiration Dates
Lot # NC194068, Exp Date: 10/29/2027.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0819-2026

VASOPRESSIN IN 0.9% SODIUM CHLORIDE

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12.
Lots / Batch Codes & Expiration Dates
Lot # NC185448, Exp Date: 8/31/2027; Lot # NC192910, Exp Date: 4/30/2028; Lot # NC195218, Exp Date: 6/30/2028.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0820-2026

VANCOMYCIN HYDROCHLORIDE

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01.
Lots / Batch Codes & Expiration Dates
Lot # NC193894, Exp Date: 04/25/2027.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0809-2026

FAMOTIDINE

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41.
Lots / Batch Codes & Expiration Dates
Lot # NC188586, Exp Date: 02/28/2027; Lot # NC188913, Exp Date: 3/9/2027.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class III (Low Risk)
Drug recall Recall #: D-0822-2026

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Bionpharma Inc.
Reason for Recall: Presence of Foreign Tablets/Capsules
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.
Lots / Batch Codes & Expiration Dates
Lot # DMA25006, Exp Date: 11/30/2028.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0806-2026

MYXREDLIN

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12.
Lots / Batch Codes & Expiration Dates
Lot # NC188630, NC188708, NC188791, NC188845, NC188876, NC188968, Exp Date: 12/31/2027; Lot # NC193719, NC193849, Exp Date: 04/30/2028; Lot # NC194051, NC194105, Exp Date: 05/31/2028; Lot # NC195171, Exp Date: 06/30/2028.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0829-2026

Broadway Joe's Pain Cream

Manufacturer / Recalling Firm: Lexia LLC
Reason for Recall: CGMP Deviations: Potential contamination of raw material
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4
Lots / Batch Codes & Expiration Dates
Lot #: T1110, Exp: 1/7/2027; T1111, Exp: 1/9/2027; T1112, Exp: 1/16/2027; T1113, Exp: 1/17/2027; T1114, Exp: 1/17/2027
Distribution Scope
Distributed in the state of Colorado (US).
Class II (Moderate Risk)
Drug recall Recall #: D-0817-2026

CLINDAMYCIN PHOSPHATE

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4114-50.
Lots / Batch Codes & Expiration Dates
Lot # NC194075, Exp Date: 10/29/2027.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0825-2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL

Manufacturer / Recalling Firm: Allies Group Inc.
Reason for Recall: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733
Lots / Batch Codes & Expiration Dates
Lots: H22V02A, Exp. 8/30/2026; C13W01B, Exp. 3/27/2027; C24W01, Exp. 4/28/2027; G23W02, Exp. 7/25/2027; G23W01B, Exp. 7/24/2027; K10W02, Exp. 10/21/2028.
Distribution Scope
Nationwide within the U.S.A
Class II (Moderate Risk)
Drug recall Recall #: D-0810-2026

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.
Lots / Batch Codes & Expiration Dates
Lot # NC188654, Exp Date: 08/31/2027; Lot # NC188821, Exp Date: 09/30/2027; Lot # NC193658, NC193702, Exp Date: 01/31/2028.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0823-2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL

Manufacturer / Recalling Firm: Allies Group Inc.
Reason for Recall: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224
Lots / Batch Codes & Expiration Dates
Lots: H22V01 Exp. 8/29/2026, H22V02 Exp. 8/30/2026, K22V02A Exp. 10/29/2026, M10V01 Exp. 01/21/2027, G23W02B Exp. 7/25/2027, G23W03 Exp. 8/4/2027, G23W03D Exp. 8/4/2027, K10W01A Exp. 10/17/2028, K10W01C Exp. 10/17/2028, M11W02 12/17/2028, F09X02 Exp. 6/17/2029.
Distribution Scope
Nationwide within the U.S.A
Class II (Moderate Risk)
Drug recall Recall #: D-0808-2026

CLINDAMYCIN PHOSPHATE

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.
Lots / Batch Codes & Expiration Dates
Lot # NC193764, Exp Date: 10/18/2027; Lot # NC195232, Exp Date: 11/25/2027.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0814-2026

NEXTERONE

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
Lots / Batch Codes & Expiration Dates
Lot # NC177832, Exp Date: 12/31/2026; Lot # NC185417, NC185455, Exp Date: 08/31/2027; Lot # NC188593, Exp Date: 11/30/2027; Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027; Lot # NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028; Lot # NC194082, NC194112, NC194143, NC195157, Exp Date: 05/31/2028.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0807-2026

Daptomycin

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0714-24.
Lots / Batch Codes & Expiration Dates
Lot # NC188692, Exp Date: 11/22/2027.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0828-2026

Broadway Joe's Pain Cream

Manufacturer / Recalling Firm: Lexia LLC
Reason for Recall: CGMP Deviations: Potential contamination of raw material
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7
Lots / Batch Codes & Expiration Dates
Lot #: T1110, Exp: 1/7/2027; T1111, Exp: 1/9/2027; T1112, Exp: 1/16/2027; T1113, Exp: 1/17/2027; T1114, Exp: 1/17/2027
Distribution Scope
Distributed in the state of Colorado (US).
Class II (Moderate Risk)
Drug recall Recall #: D-0812-2026

PANTOPRAZOLE SODIUM

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-9648-12.
Lots / Batch Codes & Expiration Dates
Lot # NC194129, Exp Date: 05/07/2028.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0826-2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL

Manufacturer / Recalling Firm: Allies Group Inc.
Reason for Recall: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853
Lots / Batch Codes & Expiration Dates
Lots: G23W03B, Exp. 8/4/2027; A16X02, Exp. 1/20/2029: A16X03, Exp. 1/22/2029.
Distribution Scope
Nationwide within the U.S.A
Class II (Moderate Risk)
Drug recall Recall #: D-0824-2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL

Manufacturer / Recalling Firm: Allies Group Inc.
Reason for Recall: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293
Lots / Batch Codes & Expiration Dates
Lots: C13W01A, Exp. 3/27/2027; G23W01A, Exp. 7/24/2027; M04W01, Exp. 12/10/2028.
Distribution Scope
Nationwide within the U.S.A
Class II (Moderate Risk)
Drug recall Recall #: D-0834-2026

TRAZODONE HYDROCHLORIDE

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Presence of Foreign Tablets/Capsules
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01
Lots / Batch Codes & Expiration Dates
Lot: 1394026, Exp. 02/2028.
Distribution Scope
U.S. Nationwide

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