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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 581–600 of 999 factual FDA recall reports
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
Class II (Moderate Risk)
Drug recall Recall #: D-0117-2026

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, 8mg/3.2mL (2.5 mg/mL), 3.2mL 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 Prorx051525-1, Prorx051525-2, Prorx051525-3 and Prorx051525-4
Distribution Scope
TX and UT
Class III (Low Risk)
Drug recall Recall #: D-0140-2026

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 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91
Lots / Batch Codes & Expiration Dates
Lot #: 550167301, 550167401, Exp. Date NOV-25; 550185101, Exp. Date MAR-26; 550205701, Exp. Date JUL-26
Distribution Scope
Nationwide within the United States
Class III (Low Risk)
Drug recall Recall #: D-0138-2026

Espumil

Manufacturer / Recalling Firm: Letco Medical LLC
Reason for Recall: Labeling: Not Elsewhere Classified
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Lots / Batch Codes & Expiration Dates
Batch # 24G15-T02-115604, exp. 11/30/2026
Distribution Scope
Product was distributed to: Letco Medical, LLC 1316 Commerce Drive Decatur, AL 35601 Product was further distributed to 44 compounding pharmacies and 2 distributors.
Class II (Moderate Risk)
Drug recall Recall #: D-0125-2026

Testosterone 62.5 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 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
Lots / Batch Codes & Expiration Dates
Lot 3180, EXP 2/17/2026
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall Recall #: D-0108-2026

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, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Lots / Batch Codes & Expiration Dates
Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0124-2026

Testosterone 50MG

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 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01
Lots / Batch Codes & Expiration Dates
Lot 3179, EXP 02/17/2026
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall Recall #: D-0104-2026

PRAZOSIN HYDROCHLORIDE

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
Lots / Batch Codes & Expiration Dates
a) NDC 0093-4067-01: Lot # 3010544A and 3010545A, Exp Date: 10/2025; Lot # 3010567A, Exp Date: 12/2025; Lot # 3010590A, Exp Date: 02/2026; Lot # 3010601A, 3010602A, 3010603A, Exp Date: 03/2026; Lot # 3010652A, 3010670A, 3010671A, Exp Date: 07/2026; Lot # 3010678A, 3010700A, 3010701A, Exp Date: 08/2026 b) NDC 0093-4067-10: Lot # 3010440A, Exp Date:...
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0149-2026

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, 60 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 57664-051-88.
Lots / Batch Codes & Expiration Dates
Lot #: AD48711, Expiry: 4/30/2026; AD50896, Expiry: 5/31/2026.
Distribution Scope
U.S Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0118-2026

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, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06
Lots / Batch Codes & Expiration Dates
Lot Prorx051525-5
Distribution Scope
TX and UT
Class II (Moderate Risk)
Drug recall Recall #: D-0105-2026

PRAZOSIN HYDROCHLORIDE

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
Lots / Batch Codes & Expiration Dates
a) NDC 0093-4068-01: Lot # 3010398A, 3010399A, 3010400A, 3010401A, 3010353A, Exp Date: 12/2025; Lot # 3010439A, 3010388A, Exp Date: 01/2026; Lot # 3010526A, 3010527A, Exp Date: 03/2026; Lot # 3010591A, 07/2026; Lot # 3010343A, Exp Date: 10/2025; Lot # 3010352A, Exp Date: 11/2025; Lot # 3010468A, 3010469A, 3010461A, Exp Date: 02/2026; Lot # 3010629A...
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0131-2026

Testosterone / Triamcinolone Acetonide 25MG/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 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01
Lots / Batch Codes & Expiration Dates
Lot: 3148, 3154, 3155, Exp 2/5/2026; 3162, Exp 2/11/2026; 3167, Exp 2/12/2026
Distribution Scope
Nationwide in the USA and Antigua

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