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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
8 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 181–200 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0683-2026

FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB

Manufacturer / Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.
Lots / Batch Codes & Expiration Dates
Lot: 1505124, 1505311, 1505332, expires: 2027-04.
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0685-2026

LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB

Manufacturer / Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.
Lots / Batch Codes & Expiration Dates
Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0679-2026

CLINERE EAR WAX REMOVER

Manufacturer / Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
Lots / Batch Codes & Expiration Dates
Lot: a) 1504241, exp 2027-03; b) 1504291, 1504301, exp 2027-03.
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0680-2026

QUALITY CHOICE EARWAX REMOVAL KIT

Manufacturer / Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.
Lots / Batch Codes & Expiration Dates
Lot: a) 1505121, 1505342, exp 2027-04; b) 1505381, exp 2027-04.
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0689-2026

CLEVIPREX

Manufacturer / Recalling Firm: Chiesi USA, Inc.
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.
Lots / Batch Codes & Expiration Dates
Lot #: 1239521, 1237454, Exp. Date 10/2027
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0664-2026

Methohexital Sodium

Manufacturer / Recalling Firm: QuVa Pharma, Inc.
Reason for Recall: Failed Impurities/Degradation Specifications
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.
Lots / Batch Codes & Expiration Dates
Lot #: 10162261, 10162262, 10162279, 10162280, Exp. Date 07/21/2026; 10162314, 10162315, Exp. Date 07/22/2026; 10162465, 10162466, 10162491, 10162492, Exp. Date 07/26/2026; 10162542, 10162543, Exp. Date 07/27/2026; 10162559, 10162560, Exp. Date 07/28/2026; 10162623, 10162624, Exp. Date 07/29/2026; 10162693, 10162694, Exp. Date 07/30/2026; 10162735...
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0669-2026

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%

Manufacturer / Recalling Firm: Gasco Industrial Corp.
Reason for Recall: Subpotent drug
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529
Lots / Batch Codes & Expiration Dates
Lots 250109B1, 250110B1, 250228B1, 250303B1, 250304B1, 250305B1, 250306B1, 250306B2 within expiry
Distribution Scope
Nationwide within the US
Class II (Moderate Risk)
Drug recall Recall #: D-0663-2026

Medline Remedy Specialized Silicone Cream

Manufacturer / Recalling Firm: BioMed Laboratories, LLC.
Reason for Recall: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04
Lots / Batch Codes & Expiration Dates
Lots 0001882643, 0001887165, 0001888441, 0001900835, 0001931329 & 0001951664 May 2026 Lots 0001882644, 0001899186, 0001903516, 0001905970, 0001911902, 0001917707 & 0001920638 June 2026 Lot 0001927080 Oct 2026 Lots 0001937896, 0001952194 & 0001962232, Jan-2027 Lots 0001981964, 0001981965, 0001994680 & 002012768, May 20...
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0674-2026

Azacitidine for Injection 100mg/Vial

Manufacturer / Recalling Firm: Reliance Life Sciences Private Limited
Reason for Recall: Lack of Sterility Assurance
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01
Lots / Batch Codes & Expiration Dates
Lot, expiry: RAZM0425A Jun 30, 2027; RAZM0525A Jun 30, 2027; RAZM0725A Jun 30, 2027; RAZM0825A Jun 30, 2027; RAZM0925A Jul 31, 2027; RAZM1125A Jul 31, 2027; RAZM1225A Jul 31, 2027; RAZM1425A Jul 31, 2027; RAZM1525A Jul 31, 2027; RAZM1625A Aug 31, 2027; RAZM1725A Aug 31, 2027; RAZM2025A Sep 30, 2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0671-2026

Pemetrexed for Injection 100mg/Vial

Manufacturer / Recalling Firm: Reliance Life Sciences Private Limited
Reason for Recall: Lack of Sterility Assurance
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01
Lots / Batch Codes & Expiration Dates
Lot, expiry: RPTL0325A Dec 31, 2027; RPTL0425A Dec 31, 2027; RPTL0624B Nov 30,2027; RPTL0625A Mar 31, 2028
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0673-2026

Bortezomib for Injection 3.5mg/Vial

Manufacturer / Recalling Firm: Reliance Life Sciences Private Limited
Reason for Recall: Lack of Sterility Assurance
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01
Lots / Batch Codes & Expiration Dates
Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0668-2026

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%

Manufacturer / Recalling Firm: Gasco Industrial Corp.
Reason for Recall: Subpotent drug
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924
Lots / Batch Codes & Expiration Dates
Lots 250221A5, 250224A2 within expiry
Distribution Scope
Nationwide within the US
Class II (Moderate Risk)
Drug recall Recall #: D-0665-2026

Gasco Isopropyl Alcohol 70%

Manufacturer / Recalling Firm: Gasco Industrial Corp.
Reason for Recall: Subpotent drug
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3
Lots / Batch Codes & Expiration Dates
Lot 250306B3, within expiry
Distribution Scope
Nationwide within the US
Class II (Moderate Risk)
Drug recall Recall #: D-0672-2026

Pemetrexed for Injection 500mg/Vial

Manufacturer / Recalling Firm: Reliance Life Sciences Private Limited
Reason for Recall: Lack of Sterility Assurance
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01
Lots / Batch Codes & Expiration Dates
Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0691-2026

Clomiphene Citrate USP Active Pharmaceutical Ingredient

Manufacturer / Recalling Firm: Shimoga Chemicals
Reason for Recall: cGMP deviations
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.
Lots / Batch Codes & Expiration Dates
Lot #: a) CC/004/24-25, Exp Date September 2029; CC0032526, Exp. Date August 2030 b) CC0442526, Exp. Date Aug 2030; CC/005/24-25, Exp. Date November 2029 c) CC0032526, Exp. Date August 2030; CC/009/24-25, Exp. Date January 2030;CC/005/24-25, Exp. Date November 2029.
Distribution Scope
CA & FL only
Class II (Moderate Risk)
Drug recall Recall #: D-0670-2026

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%

Manufacturer / Recalling Firm: Gasco Industrial Corp.
Reason for Recall: Subpotent drug
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.
Lots / Batch Codes & Expiration Dates
Lots 250206B1, 250218B2, 250507B1, within expiry
Distribution Scope
Nationwide within the US
Class II (Moderate Risk)
Drug recall Recall #: D-0667-2026

Gasco Isopropyl Alcohol 70%

Manufacturer / Recalling Firm: Gasco Industrial Corp.
Reason for Recall: Subpotent drug
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.
Lots / Batch Codes & Expiration Dates
Lot 250218B3, within expiry
Distribution Scope
Nationwide within the US
Class II (Moderate Risk)
Drug recall Recall #: D-0666-2026

Gasco Isopropyl Alcohol 70%

Manufacturer / Recalling Firm: Gasco Industrial Corp.
Reason for Recall: Subpotent drug
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA
Lots / Batch Codes & Expiration Dates
Lots 250108A2, 250109A1, 250115A1, 250124A1, 250213A1, 250220Z3, 250221A3, 250221A4, 250224A1, 250303A3, 250306A1, 250307A1, within expiry
Distribution Scope
Nationwide within the US
Class II (Moderate Risk)
Drug recall Recall #: D-0662-2026

METHOHEXITAL SODIUM

Manufacturer / Recalling Firm: ONESOURCE SPECIALTY PHARMA LIMITED
Reason for Recall: Failed Impurities/Degradation Specifications
FDA Report: Jul 15, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31
Lots / Batch Codes & Expiration Dates
Lot #: 7000612A, Exp. Date 1/2028
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0657-2026

Synjardy XR Tablets

Manufacturer / Recalling Firm: Boehringer Ingelheim Pharmaceuticals, Inc.
Reason for Recall: CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
FDA Report: Jul 08, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45
Lots / Batch Codes & Expiration Dates
Lot 3244413; Exp. 12/31/2028
Distribution Scope
OH

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