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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 381–400 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0312-2026

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, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.
Lots / Batch Codes & Expiration Dates
Lot#: 253000124, Exp. 06/02/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0337-2026

vancomycin HCl

Manufacturer / Recalling Firm: Fresenius Kabi Compounding, LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
Lots / Batch Codes & Expiration Dates
Lot # C274-000047611, Exp Date: 10-Feb-26; Lot # C274-000049633, Exp Date: 12-May-26.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0329-2026

Testosterone 200mg

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 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
Lots / Batch Codes & Expiration Dates
Lot#: 256000105, Exp. 09/19/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0308-2026

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, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
Lots / Batch Codes & Expiration Dates
Lot#: 253000132, Exp. 06/16/2026; 253000139, 253000140, Exp. 07/21/2026; 253000150, Exp. 08/08/2026; 253000151, Exp. 08/16/2026; 253000161, 253000162, Exp. 09/12/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0322-2026

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, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
Lots / Batch Codes & Expiration Dates
Lot#: 251000145, Exp. 07/14/2026; 251000161, Exp. 08/16/2026; 251000175, Exp. 09/08/2026. .
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0336-2026

vancomycin HCl

Manufacturer / Recalling Firm: Fresenius Kabi Compounding, LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59
Lots / Batch Codes & Expiration Dates
Lot # C274-000049628, Exp Date: 3-May-26.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0314-2026

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, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
Lots / Batch Codes & Expiration Dates
Lot#: 253000136, Exp. 07/01/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0318-2026

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, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
Lots / Batch Codes & Expiration Dates
Lot#: 251000130, Exp. 06/02/2026; 251000137, 06/19/2026; 251000152, Exp. 08/02/2026; 251000168, Exp. 08/29/2026; 251000170, Exp. 09/03/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0324-2026

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, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
Lots / Batch Codes & Expiration Dates
Lot#: 251000127, Exp. 06/03/2026; 251000128, Exp. 06/05/2026; 251000133, 251000134, 251000135, Exp. 06/16/2026; 251000138, 251000139, 251000140, 251000141, Exp. 06/25/2026; 251000147, 251000148, 251000149, Exp. 07/28/2026; 251000156, 251000157, Exp. 08/08/2026; 251000164, 251000165, 251000166, Exp. 08/22/2026; 251000169, Exp. 08/29/2026; 251000171,...
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0338-2026

OXYCODONE HYDROCHLORIDE

Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11
Lots / Batch Codes & Expiration Dates
Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0334-2026

ketamine HCl

Manufacturer / Recalling Firm: Fresenius Kabi Compounding, LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56
Lots / Batch Codes & Expiration Dates
Lot # C274-000047883, Exp Date: 17-Feb-26; Lot # C274-000048515, Exp Date: 22-Mar-26; Lot # C274-000048679, Exp Date: 31-Mar-26; Lot # C274-000049119, Exp Date: 19-Apr-26; Lot # C274-000049282, Exp Date: 27-Apr-26
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0335-2026

thiamine HCl

Manufacturer / Recalling Firm: Fresenius Kabi Compounding, LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
Lots / Batch Codes & Expiration Dates
Lot # C274-000047651, Exp Date: 7-Feb-26; Lot # C274-000048671, Exp Date: 30-Mar-26; Lot # C274-000048828, Exp Date: 7-Apr-26; Lot # C274-000049121, Exp Date: 19-Apr-26; Lot # C274-000049127, Exp Date: 21-Apr-26; Lot # C274-000049252, Exp Date: 26-Apr-26; Lot # C274-000049260, Exp Date: 28-Apr-26; Lot # C274-000049401, Exp Date: 3-May-26; Lot # C2...
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0302-2026

PRO NUMB

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, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11
Lots / Batch Codes & Expiration Dates
Lot Numbers J01 through J14, J55 through J69
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0323-2026

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, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.
Lots / Batch Codes & Expiration Dates
Lot#: 251000132, Exp. 06/16/2026; 251000142, Exp. 06/30/2026; 251000144, Exp. 07/14/2026; 251000146, Exp. 07/21/2026; 251000162, 251000163, Exp. 08/16/2026; 251000167, Exp. 08/22/2026; 251000177, Exp. 09/12/2026.
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0353-2026

UDENYCA

Manufacturer / Recalling Firm: McKesson
Reason for Recall: Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
Lots / Batch Codes & Expiration Dates
Subset of Lot 2199821, Expires: 05/31/2027 Specific Serial Numbers being Recalled: 160R694TT06X; 1C74A686RPPG; 1W6A2M777N3V; 20825394KR8P; 242E2RK3EA92; 2DG49VH89EPG; 2WEA2ADK1P4H; 3KR2TVAG3VDH; 42M0V0G9PM84; 46E9XKDPTH1R; 4AM12WEAE48H; 4FGHR096DMNV; 4MWGWM991XNA; 4NEW8XD9DNM2; 4Y2PYDFN9YA1; 61EPX42R4K2A; 63FN9VW5CAV7; 69TG160DW2CV; 69XFP3TMTP7X; 6...
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0332-2026

Rheumacare capsules

Manufacturer / Recalling Firm: HANDELNINE GLOBAL LLC
Reason for Recall: CGMP Deviations: product found to contain lead.
FDA Report: Feb 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
Lots / Batch Codes & Expiration Dates
Lot: CAM040, Exp. 06/30/2029 Lot: CAL079-N, Exp. 09/30/2028
Distribution Scope
Product was distributed to one customer in NY.
Class II (Moderate Risk)
Drug recall Recall #: D-0342-2026

DICLOFENAC SODIUM

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
FDA Report: Feb 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7
Lots / Batch Codes & Expiration Dates
Lot # AD92721, Exp Date: 3/31/2027.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0305-2026

TRAZODONE HYDROCHLORIDE

Manufacturer / Recalling Firm: Granules Pharmaceuticals Inc.
Reason for Recall: Presence of Foreign Tablets/Capsules
FDA Report: Feb 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
Lots / Batch Codes & Expiration Dates
Batch # 6160008A, Exp Date: 12/31/2026
Distribution Scope
US Nationwide.
Class I (High Risk)
Drug recall Recall #: D-0304-2026

Green Lumber Natural Fuel For Men capsule

Manufacturer / Recalling Firm: Green Lumber Holdings, LLC
Reason for Recall: Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
FDA Report: Feb 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660
Lots / Batch Codes & Expiration Dates
LOT308EXP03/28
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0301-2026

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Manufacturer / Recalling Firm: Unichem Pharmaceuticals USA Inc.
Reason for Recall: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
FDA Report: Feb 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
Lots / Batch Codes & Expiration Dates
Lot # GBHL24005A, Exp Date: 09/2026
Distribution Scope
US Nationwide and PR.

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