Home
Disease Vault Drug Index & Alternatives Drug Interactions Pregnancy Drug Safety Drug Recalls & Alerts OTC Navigator
Medical Bot Med Lab Clinical Cases Nutrition & Macro Calculator
Questo Insights Global Opportunities Paper Helper Citation Generator Scholarships & Travel Visa & Mobility Navigator English Assessment Test
Med Jobs Med Lounge Pharma Swap Pharmacies Directory Medical Case Donations Opportunity Crowdfunding
Courses Academy Quiz Arena Memory Palace STEM Academy Toolkits
About Us Contact Us Privacy Policy Terms of Service
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
48 minutes 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 761–780 of 1,170 factual FDA recall reports
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
Class II (Moderate Risk)
Drug recall Recall #: D-0116-2026

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, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08
Lots / Batch Codes & Expiration Dates
Lot Prorx051425-2, Lot Prorx051425-3 and Lot Prorx051425-4
Distribution Scope
TX and UT
Class II (Moderate Risk)
Drug recall Recall #: D-0115-2026

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, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04
Lots / Batch Codes & Expiration Dates
Lot, Best Use Date (BUD): Lot PRORX050925-1, BUD November 4, 2025; Lot ProRx051425-5, BUD November 10, 2025; Lot ProRx051425-6, BUD November 10, 2025
Distribution Scope
TX and UT
Class II (Moderate Risk)
Drug recall Recall #: D-0097-2026

OPDUALAG

Manufacturer / Recalling Firm: Bristol-Myers Squibb Company
Reason for Recall: Lack of Assurance of Sterility.
FDA Report: Oct 29, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11
Lots / Batch Codes & Expiration Dates
Lot: 033A23B, Expiry: 4/30/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0036-2026

KETOROLAC TROMETHAMINE

Manufacturer / Recalling Firm: Aspiro Pharma Limited
Reason for Recall: Presence of Particulate Matter: Particulate matter identified as glass
FDA Report: Oct 29, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).
Lots / Batch Codes & Expiration Dates
Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0095-2026

ZICAM COLD REMEDY MEDICATED FRUIT DROPS - ELDERBERRY

Manufacturer / Recalling Firm: Church & Dwight Co., Inc.
Reason for Recall: Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
FDA Report: Oct 29, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25
Lots / Batch Codes & Expiration Dates
Lot#: BE51396303, Exp. Date 2027/05
Distribution Scope
Product was distributed nationwide within the United States
Class III (Low Risk)
Drug recall Recall #: D-0033-2026

CETIRIZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: JB Chemicals and Pharmaceuticals Ltd
Reason for Recall: Tablet/Capsules Imprinted with Wrong ID
FDA Report: Oct 29, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50
Lots / Batch Codes & Expiration Dates
Lot # PY925014, PY925013, Exp. 1/31/2028
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0030-2026

GABAPENTIN

Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
FDA Report: Oct 29, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61
Lots / Batch Codes & Expiration Dates
Lot # M04950, Exp Date: 01/2026; Lot # M04989, M04990, Exp Date: 02/2026; Lot # M05056, Exp Date: 04/2026; Lot # M05150, Exp Date: 07/2026; Lot # M05290, Exp Date: 11/2026; Lot # M05312, M05342, Exp Date: 01/2027; Lot # M05369, M05386, Exp Date: 02/2027.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0035-2026

Medline

Manufacturer / Recalling Firm: Medline Industries, LP
Reason for Recall: Subpotent Drug
FDA Report: Oct 29, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30.
Lots / Batch Codes & Expiration Dates
Lot #: 61224040057
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0034-2026

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %

Manufacturer / Recalling Firm: USV Private Limited
Reason for Recall: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
FDA Report: Oct 29, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05
Lots / Batch Codes & Expiration Dates
Lot #: 35000409, Exp. Date 01/2026
Distribution Scope
Nationwide within the United States

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