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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 541–560 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0310-2026

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,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
Lots / Batch Codes & Expiration Dates
Lot#: 253000118, Exp. 02/21/2026; 253000145, Exp. 08/02/2026; 253000146, Exp. 06/30/2026, 253000167, Exp. 09/23/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0317-2026

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, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.
Lots / Batch Codes & Expiration Dates
Lot#: 251000126, Exp. 06/03/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0333-2026

acyclovir sodium

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
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56
Lots / Batch Codes & Expiration Dates
Lot # C274-000049124, Exp Date: 28-Feb-26.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0309-2026

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, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.
Lots / Batch Codes & Expiration Dates
Lot#: 253000117, Exp. 02/21/2026; 253000129, Exp. 06/12/2026; 253000130, Exp. 06/16/2026; 253000154, 253000155, Exp. 08/29/2026; 253000160, Exp. 09/10/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0315-2026

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, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.
Lots / Batch Codes & Expiration Dates
Lot#: 253000125, Exp. 06/09/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0328-2026

Testosterone 100mg

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, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
Lots / Batch Codes & Expiration Dates
Lot#: 256000104, Exp. 07/30/2026. .
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0325-2026

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, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.
Lots / Batch Codes & Expiration Dates
Lot#: 251000124, Exp. 06/02/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0326-2026

Testosterone 100mg

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 (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.
Lots / Batch Codes & Expiration Dates
Lot#: 254000104, Exp. 05/27/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0316-2026

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, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.
Lots / Batch Codes & Expiration Dates
Lot#: 251000143, Exp. 07/07/2026; 251000160, Exp. 08/16/2026.
Distribution Scope
Nationwide in the USA
Class III (Low Risk)
Drug recall Recall #: D-0306-2026

DOXAZOSIN MESYLATE

Manufacturer / Recalling Firm: Unichem Pharmaceuticals USA Inc.
Reason for Recall: Tablets/Capsules Imprinted with Wrong ID
FDA Report: Feb 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.
Lots / Batch Codes & Expiration Dates
Lot # GDSH25006, Exp Date: 08/2027
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0321-2026

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, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.
Lots / Batch Codes & Expiration Dates
Lot#: 251000125, Exp. 06/02/2026.
Distribution Scope
Nationwide in the USA
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

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