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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
3 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 521–540 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0348-2026

VISTA MEIBO TEARS PROPYLENE GLYCOL 0.6% W/V ADVANCED DRY EYE RELIEF LUBRICATING DROPS 10 ML

Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA Report: Mar 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0345-2026

Agebox iKids-Growth

Manufacturer / Recalling Firm: Agebox
Reason for Recall: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
FDA Report: Mar 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
Lots / Batch Codes & Expiration Dates
Lot # 23101202 exp 09/2026, 24080802 exp 07/2027, and 25020702 exp 01/2028
Distribution Scope
The product was distributed nationwide in the U.S. Agebox sells its U.S. products through Agebox.com (using Shopify) and Amazon.com. All orders are shipped to customers by Agebox itself; other parties are not involved in the distribution of the physical product.
Class II (Moderate Risk)
Drug recall Recall #: D-0349-2026

VISTA GONIO EYE LUBRICANT

Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA Report: Mar 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0339-2026

ADBRY

Manufacturer / Recalling Firm: LEO PHARMA INC
Reason for Recall: Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
FDA Report: Mar 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,
Lots / Batch Codes & Expiration Dates
Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0347-2026

VISTA HYPROMELLOSE DRY EYE RELIEF

Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA Report: Mar 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0341-2026

AMANTADINE HCL

Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
FDA Report: Mar 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
Lots / Batch Codes & Expiration Dates
Lot # 49261, Exp: 04/30/27
Distribution Scope
Nationwide in the USA.
Class III (Low Risk)
Drug recall Recall #: D-0343-2026

EPTIFIBATIDE

Manufacturer / Recalling Firm: Slate Run Pharmaceuticals
Reason for Recall: Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
FDA Report: Mar 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
Nationwide within the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0346-2026

Vista Tears Polyethylene Glycol 400 0.4% w/v

Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA Report: Mar 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0351-2026

Bio Glo Fluorescein Sodium Ophthalmic Strips USP

Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA Report: Mar 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0352-2026

BioGlo Fluorescein Sodium Ophthalmic Strips USP

Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA Report: Mar 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0307-2026

ESTRADIOL

Manufacturer / Recalling Firm: F.H. INVESTMENTS, Inc. (dba Asteria Health)
Reason for Recall: Presence of Foreign substance - potential presence of metal particulate matter
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.
Lots / Batch Codes & Expiration Dates
Lot#: 253000127, Exp. 06/09/2026; 253000133, Exp. 06/17/2026; 253000138, Exp. 07/14/2026; 253000141, Exp. 07/21/2026; 253000144, Exp. 07/28/2026; 253000147, Exp. 08/05/2026; 253000148, Exp. 08/07/2026; 253000149, Exp. 08/08/2026; 253000152, 253000153, Exp. 08/22/2026; 253000156, Exp. 09/03/2026; 253000157, Exp. 09/04/2026; 253000159, Exp. 09/05/20...
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0327-2026

Testosterone 75mg

Manufacturer / Recalling Firm: F.H. INVESTMENTS, Inc. (dba Asteria Health)
Reason for Recall: Presence of Foreign substance - potential presence of metal particulate matter
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.
Lots / Batch Codes & Expiration Dates
Lot#: 254000107, Exp. 06/30/2026; 254000111, Exp. 08/07/2026. .
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0331-2026

Testosterone 100mg Anastrozole 4mg

Manufacturer / Recalling Firm: F.H. INVESTMENTS, Inc. (dba Asteria Health)
Reason for Recall: Presence of Foreign substance - potential presence of metal particulate matter
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32
Lots / Batch Codes & Expiration Dates
Lot#: 254000105, Exp. 05/28/2026, 254000110, Exp. 08/07/2026; 254000112, 254000113, Exp. 09/26/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0313-2026

ESTRADIOL

Manufacturer / Recalling Firm: F.H. INVESTMENTS, Inc. (dba Asteria Health)
Reason for Recall: Presence of Foreign substance - potential presence of metal particulate matter
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
Lots / Batch Codes & Expiration Dates
Lot#: 253000126, Exp. 06/09/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0303-2026

PRO NUMB SENSITIVE SKIN

Manufacturer / Recalling Firm: Pro Numb Tattoo Numbing Spray LLC
Reason for Recall: cGMP deviations
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11
Lots / Batch Codes & Expiration Dates
Lot Number J15
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0330-2026

Testosterone 87.5mg

Manufacturer / Recalling Firm: F.H. INVESTMENTS, Inc. (dba Asteria Health)
Reason for Recall: Presence of Foreign substance - potential presence of metal particulate matter
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.
Lots / Batch Codes & Expiration Dates
Lot#: 256000103, Exp. 07/28/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0311-2026

ESTRADIOL

Manufacturer / Recalling Firm: F.H. INVESTMENTS, Inc. (dba Asteria Health)
Reason for Recall: Presence of Foreign substance - potential presence of metal particulate matter
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.
Lots / Batch Codes & Expiration Dates
Lot#: 253000123, Exp. 06/02/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0319-2026

Testosterone

Manufacturer / Recalling Firm: F.H. INVESTMENTS, Inc. (dba Asteria Health)
Reason for Recall: Presence of Foreign substance - potential presence of metal particulate matter
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
Lots / Batch Codes & Expiration Dates
Lot#: 251000131, Exp. 06/16/2026; 251000136, Exp. 08/02/2026; 251000150, Exp. 08/12/2026; 251000158, Exp. 08/14/2026; 251000159, Exp. 06/16/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0340-2026

CETRORELIX ACETATE

Manufacturer / Recalling Firm: Meitheal Pharmaceuticals, Inc
Reason for Recall: Defective Delivery System: Missing or duplicated needles within the injection kit
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.
Lots / Batch Codes & Expiration Dates
Lot Q4E0112A, Exp.: 30 Apr 2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0320-2026

Testosterone

Manufacturer / Recalling Firm: F.H. INVESTMENTS, Inc. (dba Asteria Health)
Reason for Recall: Presence of Foreign substance - potential presence of metal particulate matter
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
Lots / Batch Codes & Expiration Dates
Lot#: 251000122, Exp. 04/01/2026; 251000151, Exp. 08/02/2026; 251000155, Exp. 08/08/2026; 251000173, Exp. 09/05/2026.
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

Confirm Action