Home
Disease Vault Drug Index & Alternatives Drug Interactions Pregnancy Drug Safety Drug Recalls & Alerts OTC Navigator
Medical Bot Med Lab Clinical Cases Nutrition & Macro Calculator
Questo Insights Global Opportunities Paper Helper Citation Generator Scholarships & Travel Visa & Mobility Navigator English Assessment Test
Med Jobs Med Lounge Pharma Swap Pharmacies Directory Medical Case Donations Opportunity Crowdfunding
Courses Academy Quiz Arena Memory Palace STEM Academy Toolkits
About Us Contact Us Privacy Policy Terms of Service
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
9 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 21–40 of 1,170 factual FDA recall reports
Class I (High Risk)
Drug recall Recall #: D-0866-2026

THYROID

Manufacturer / Recalling Firm: VITRUVIAS THERAPEUTICS INC
Reason for Recall: Superpotent Drug
FDA Report: Sep 23, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by: Vitruvias Therapeutics, Auburn, AL 36830, Product of USA, NDC 69680-166-00.
Lots / Batch Codes & Expiration Dates
Lot # 504950, Exp Date: 09/30/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0844-2026

Fluphenazine HCl Elixir

Manufacturer / Recalling Firm: Safecor Health, LLC
Reason for Recall: Failed Stability Specifications
FDA Report: Sep 23, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
Lots / Batch Codes & Expiration Dates
Lot#:25421159; Exp :10/21/2026 Lot#:25431644; Exp :11/03/2026 Lot#:25471687; Exp :12/02/2026 Lot#:25510930; Exp :01/05/2027 Lot#:26130247; Exp :04/17/2027 Lot#:25450648; Exp :11/30/2026 Lot#:26061716; Exp :02/28/2027 Lot#:26120384; Exp :03/27/2027 Lot#:26141493; Exp :04/07/2027 Lot#:26190055; Exp :05/04/2027 Lot#:26231530; Exp :06/05/2027
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0846-2026

Fluphenazine HCl Elixir

Manufacturer / Recalling Firm: Safecor Health, LLC
Reason for Recall: Failed Stability Specifications
FDA Report: Sep 23, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
Lots / Batch Codes & Expiration Dates
Lot#:25330415; Exp :08/26/2026 Lot#:25340169; Exp :09/05/2026 Lot#:25380387; Exp :10/17/2026 Lot#:25410936; Exp :11/13/2026 Lot#:25450649; Exp :11/30/2026 Lot#:25471328; Exp :01/05/2027 Lot#:26120385; Exp :03/27/2027 Lot#:26141494; Exp :04/07/2027 Lot#:26170183; Exp :04/21/2027 Lot#:26220497; Exp :05/28/2027
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0845-2026

Fluphenazine HCl Elixir

Manufacturer / Recalling Firm: Safecor Health, LLC
Reason for Recall: Failed Stability Specifications
FDA Report: Sep 23, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
Lots / Batch Codes & Expiration Dates
Lot#:26080483; Exp :03/13/2027 Lot#:25310327; Exp :08/12/2026 Lot#:25330414; Exp :08/26/2026 Lot#:25430340; Exp :11/22/2026
Distribution Scope
Nationwide in the USA.
Class I (High Risk)
Drug recall Recall #: N/A

NYSTATIN

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Stability Specifications
FDA Report: Sep 23, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-1289-1
Lots / Batch Codes & Expiration Dates
LOT AD49605, LOT AD49606; Exp. 05/31/2027
Distribution Scope
U.S. Nationwide.
Class I (High Risk)
Drug recall Recall #: D-0869-2026

SODIUM CHLORIDE

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
FDA Report: Sep 16, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.
Lots / Batch Codes & Expiration Dates
Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.
Distribution Scope
Nationwide within the United States
Class I (High Risk)
Drug recall Recall #: D-0865-2026

EPINEPHRINE

Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
FDA Report: Sep 16, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01
Lots / Batch Codes & Expiration Dates
Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
Distribution Scope
Nationwide within the U.S.A
Class II (Moderate Risk)
Drug recall Recall #: D-0864-2026

fentaNYL Citrate

Manufacturer / Recalling Firm: OurPharma LLC
Reason for Recall: Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
FDA Report: Sep 16, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.
Lots / Batch Codes & Expiration Dates
Lot #: 101301260605, BUD: 12/9/2026.
Distribution Scope
Nationwide within the U.S
Class I (High Risk)
Drug recall Recall #: D-0850-2026

Dextrose Injection

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
FDA Report: Sep 16, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
Lots / Batch Codes & Expiration Dates
Lot #: Y495066, Exp. Date July 31, 2027
Distribution Scope
U.S. Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0836-2026

FLUPHENAZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Ajanta Pharma USA Inc
Reason for Recall: Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
FDA Report: Sep 16, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
Lots / Batch Codes & Expiration Dates
Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
Distribution Scope
Nationwide within the U.S
Class III (Low Risk)
Drug recall Recall #: D-0835-2026

Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution

Manufacturer / Recalling Firm: ImprimisRx NJ LLC
Reason for Recall: Subpotent Drug
FDA Report: Sep 16, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10
Lots / Batch Codes & Expiration Dates
Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0847-2026

PRASUGREL

Manufacturer / Recalling Firm: Golden State Medical Supply Inc.
Reason for Recall: Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.
Lots / Batch Codes & Expiration Dates
Lot # GS062298, Exp Date: 09/30/ 2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0839-2026

PRASUGREL

Manufacturer / Recalling Firm: Mylan Pharmaceuticals Inc
Reason for Recall: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
Lots / Batch Codes & Expiration Dates
Lot #: 3225272, Exp. September 30, 2026
Distribution Scope
Nationwide within the U.S
Class III (Low Risk)
Drug recall Recall #: D-0838-2026

REVCOVI

Manufacturer / Recalling Firm: Chiesi USA, Inc.
Reason for Recall: Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01
Lots / Batch Codes & Expiration Dates
Lot#: 1221973, Exp 3/24/2027
Distribution Scope
MO, TN
Class II (Moderate Risk)
Drug recall Recall #: D-0837-2026

CHLORHEXIDINE GLUCONATE

Manufacturer / Recalling Firm: Sage Products, LLC
Reason for Recall: Cross Contamination with Other Products
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26
Lots / Batch Codes & Expiration Dates
Lot 108491 with case sequence numbers 14841 through 20013.
Distribution Scope
US Nationwide.
Class I (High Risk)
Drug recall Recall #: D-0849-2026

SODIUM CHLORIDE

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: Presence of particulate matter: Particulates identified as fiberglass
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03
Lots / Batch Codes & Expiration Dates
Lot: Y495523, Y495523A, Exp 31-Oct-2027
Distribution Scope
Natonwide in the USA
Class III (Low Risk)
Drug recall Recall #: D-0840-2026

BUPRENORPHINE

Manufacturer / Recalling Firm: American Health Packaging
Reason for Recall: Labeling: Label Mix-up
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).
Lots / Batch Codes & Expiration Dates
Lot # 1030023, Exp Date: 06/30/2027.
Distribution Scope
US Nationwide.
Class I (High Risk)
Drug recall Recall #: D-0851-2026

Glutathione 200 mg/mL

Manufacturer / Recalling Firm: OPTIMAL BALANCE PHARMACY
Reason for Recall: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090
Lots / Batch Codes & Expiration Dates
Lot#: LG342009076, Beyond Use Date: 10/4/26
Distribution Scope
USA Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0830-2026

MYCOPHENOLATE MOFETIL

Manufacturer / Recalling Firm: Mylan Pharmaceuticals Inc
Reason for Recall: Failed Dissolution Specifications
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.
Lots / Batch Codes & Expiration Dates
Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0816-2026

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 Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.
Lots / Batch Codes & Expiration Dates
Lot # NC193689, Exp Date: 10/16/2027.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.

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