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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
1 hour 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 741–760 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0107-2026

DESIPRAMINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Heritage Pharmaceuticals Inc
Reason for Recall: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Lots / Batch Codes & Expiration Dates
Lot#: 18036908, Exp. Date: 09/30/2026
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0133-2026

Testosterone / Triamcinolone Acetonide 50MG/10MCG

Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01
Lots / Batch Codes & Expiration Dates
Lot: 3091, 3096, Exp 1/7/2026; 3097, Exp 1/7/2026; 3182, 3186, 3187, 3188, Exp 2/10/2026
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall Recall #: D-0128-2026

Testosterone Regular Release 50 MG

Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01
Lots / Batch Codes & Expiration Dates
Lot: 3178, Exp 02/7/2026
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall Recall #: D-0135-2026

Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG

Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01
Lots / Batch Codes & Expiration Dates
Lot, expiry: 3194, 3195, Exp 2/17/2026; 3196, 3197, Exp 2/18/2026.
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall Recall #: D-0137-2026

Testosterone / Triamcinolone Acetonide Pellet

Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01
Lots / Batch Codes & Expiration Dates
Lot, expiry: 3075, Exp 1/2/2026; 3084, Exp 1/6/2026; 3110, Exp 1/15/2026; 3115, Exp 1/16/2026; 3116, Exp 1/20/2026; 3119, Exp 1/21/2026; 3121, Exp 1/22/2026; 3124, Exp 1/23/2026; 3125, Exp 1/28/2026; 3131, Exp 1/29/2026; 3134, Exp 2/3/2026; 3135, Exp 2/4/2026; 3139, Exp 2/6/2026; 3204, Exp 2/13/2026; 3205, Exp 2/18/2026; 3207, Exp 2/19/2026; 3208,...
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall Recall #: D-0102-2026

PRAZOSIN HYDROCHLORIDE

Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11
Lots / Batch Codes & Expiration Dates
Lot #: 1020109, Exp. Date 02/28/2026; 1024343, 1025355, Exp. Date 09/30/2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0123-2026

Testosterone 25MG

Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01
Lots / Batch Codes & Expiration Dates
Lot 3294, EXP 4/8/2026
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall Recall #: D-0143-2026

SODIUM CHLORIDE

Manufacturer / Recalling Firm: Otsuka ICU Medical LLC
Reason for Recall: Lack of Assurance of Sterility: Potential for flexible container leaks.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Lots / Batch Codes & Expiration Dates
Lot # 1029921, Exp Date: 28 February 2027
Distribution Scope
Distributed Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0119-2026

Semaglutide Injection

Manufacturer / Recalling Firm: ProRx LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02
Lots / Batch Codes & Expiration Dates
Lot PRORX052125-4
Distribution Scope
TX and UT
Class II (Moderate Risk)
Drug recall Recall #: D-0132-2026

Testosterone / Triamcinolone Acetonide Pellet

Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01
Lots / Batch Codes & Expiration Dates
Lot, expiry: 3143, Exp 2/5/2026; 3160, 3161, Exp 2/11/2026; 3165, 3166, Exp 2/12/2026.
Distribution Scope
Nationwide in the USA and Antigua
Class III (Low Risk)
Drug recall Recall #: D-0142-2026

EVEROLIMUS

Manufacturer / Recalling Firm: Endo USA, Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91
Lots / Batch Codes & Expiration Dates
Lot #: 550172201, Exp. Date JAN-26; 550184801, Exp. Date MAR-26; 550204001, Exp. Date JUL-26
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0130-2026

Testosterone / Triamcinolone Acetonide

Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01
Lots / Batch Codes & Expiration Dates
Lot# 3171, 3172, Exp 2/11/2026
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall Recall #: D-0114-2026

Semaglutide Injection

Manufacturer / Recalling Firm: ProRx LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
Lots / Batch Codes & Expiration Dates
Lot# Prorx04282025-3
Distribution Scope
TX and UT
Class II (Moderate Risk)
Drug recall Recall #: D-0103-2026

PRAZOSIN HYDROCHLORIDE

Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33
Lots / Batch Codes & Expiration Dates
Lot #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0148-2026

LISDEXAMFETAMINE DIMESYLATE

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-050-88.
Lots / Batch Codes & Expiration Dates
Lot #:AD48710, Expiry: 4/30/2026; AD50895, Expiry: 5/31/2026.
Distribution Scope
U.S Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0121-2026

TYLENOL EXTRA STRENGTH

Manufacturer / Recalling Firm: Kenvue Brands LLC
Reason for Recall: Defective Container
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.
Lots / Batch Codes & Expiration Dates
Lot: EJA022, expiry: 04/30/2028
Distribution Scope
U.S. Nationwide - CO, IL, OH and IN.
Class II (Moderate Risk)
Drug recall Recall #: D-0112-2026

DESIPRAMINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Heritage Pharmaceuticals Inc
Reason for Recall: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Lots / Batch Codes & Expiration Dates
Lot#: 18035739, Exp. Date: 11/30/2025
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0136-2026

Testosterone / Triamcinolone Acetonide Pellet

Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01
Lots / Batch Codes & Expiration Dates
Lot, expiry: 3098, 3101, Exp 1/8/2026; 3107, Exp 1/13/2026; 3108, Exp 1/14/2026; 3109, Exp 1/15/2026; 3230, Exp 3/10/2026; 3231, Exp 3/11/2026; 3235, Exp 3/13/2026; 3236, Exp 3/17/2026; 3241, Exp 3/17/2026; 3242, Exp 3/18/2026.
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall Recall #: D-0120-2026

Tirzepatide Injection

Manufacturer / Recalling Firm: ProRx LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
Lots / Batch Codes & Expiration Dates
Lot PRORX08062025-3
Distribution Scope
TX and UT
Class II (Moderate Risk)
Drug recall Recall #: D-0099-2026

HADLIMA

Manufacturer / Recalling Firm: Samsung Bioepis Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.
Lots / Batch Codes & Expiration Dates
Lot: F2505017, Expiry: 24-Jan-2027
Distribution Scope
Distributed only to one warehouse in NJ. with no further distribution

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