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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
9 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 1141–1160 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0405-2025

Carboxymethylcellulose Sodium Ophthalmic Gel 1%

Manufacturer / Recalling Firm: BRS Analytical Services, LLC
Reason for Recall: cGMP deviations and lack of assurance of sterility.
FDA Report: May 14, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 114, exp 9/04/25; Lot 115, exp 9/06/25; Lot 116, exp 9/10/25; Lot 207, exp 12/05/26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0412-2025

TESTOSTERONE PELLET 100 mg

Manufacturer / Recalling Firm: BSO LLC
Reason for Recall: Presence of Particulate Matter: Glass particles were found in pellet vials.
FDA Report: May 14, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01
Lots / Batch Codes & Expiration Dates
Lot 20250102@6, exp 12/11/2025; Lot 20250130@4, exp 1/22/2026
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0402-2025

ROPIVACAINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Amneal Pharmaceuticals, LLC
Reason for Recall: Presence of Particulate Matter
FDA Report: May 14, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)
Lots / Batch Codes & Expiration Dates
Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0403-2025

TIMOLOL MALEATE

Manufacturer / Recalling Firm: FDC Limited
Reason for Recall: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDA Report: May 14, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.
Lots / Batch Codes & Expiration Dates
Lot #: 083I098, Exp. Date 08/31/2025
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0404-2025

ARTIFICIAL TEARS

Manufacturer / Recalling Firm: BRS Analytical Services, LLC
Reason for Recall: cGMP deviations and lack of assurance of sterility.
FDA Report: May 14, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 126, exp 10/26/25; Lot 127, exp 10/30/25; Lot 128, exp 11/02/25; Lot 129, exp 11/06/25; Lot 162, exp 5/09/26; Lot 163, exp 5/14/26; Lot 164, exp 5/20/26; Lot 165, exp 5/23/26; Lot 166, exp 5/29/26; Lot 167, exp 6/03/26; Lot 168, exp 6/06/26; Lot 169, exp 6/10/26; Lot 170, exp 6/13/26; Lot 193, exp 10/07/26; Lot 194, exp 10/10/26;...
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0411-2025

Clindamycin HCl Capsule

Manufacturer / Recalling Firm: RemedyRePack Inc.
Reason for Recall: CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
FDA Report: May 14, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
Lots / Batch Codes & Expiration Dates
Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.
Distribution Scope
Within U.S - PA, VA, FL.
Class II (Moderate Risk)
Drug recall Recall #: D-0410-2025

temper tamer

Manufacturer / Recalling Firm: Siddha Flower Essences, LLC.
Reason for Recall: CGMP Deviations
FDA Report: May 14, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.
Lots / Batch Codes & Expiration Dates
Lot# S22-26424D; Exp 9/27/2027
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0394-2025

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17
Lots / Batch Codes & Expiration Dates
Lot # D2300323, Exp Date: 01/2026
Distribution Scope
Nationwide US.
Class II (Moderate Risk)
Drug recall Recall #: D-0400-2025

Medroxyprogesterone Acetate Injectable Suspension

Manufacturer / Recalling Firm: Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall: Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products...
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01
Lots / Batch Codes & Expiration Dates
Lot #: 1MP24042, Exp 6/30/26
Distribution Scope
Distributed to Medical Facilities in MS and FL.
Class II (Moderate Risk)
Drug recall Recall #: D-0395-2025

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17.
Lots / Batch Codes & Expiration Dates
Lot # D2400547, Exp Date: 02/2026
Distribution Scope
Nationwide US.
Class II (Moderate Risk)
Drug recall Recall #: D-0391-2025

Clindamycin Hydrochloride Capsules

Manufacturer / Recalling Firm: Preferred Pharmaceuticals, Inc.
Reason for Recall: cGMP Deviations
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
Lots / Batch Codes & Expiration Dates
Lot #: L0224T, K1824M, K0124N, J1624V, J0824O, I2424E, I1024O, A0925F, L2324L, Exp: 7/31/2026.
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0399-2025

NICARDIPINE HYDROCHLORIDE

Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Lots / Batch Codes & Expiration Dates
Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0401-2025

INFUVITE ADULT

Manufacturer / Recalling Firm: Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall: Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products...
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product of Canada, NDC 54643-5649-1
Lots / Batch Codes & Expiration Dates
Lot #: AA2279, Exp 8/31/26; AA2383, Exp 9/30/26
Distribution Scope
Distributed to Medical Facilities in MS and FL.
Class II (Moderate Risk)
Drug recall Recall #: D-0397-2025

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15
Lots / Batch Codes & Expiration Dates
Lot # D2400725, Exp Date: 03/2026
Distribution Scope
Nationwide US.
Class II (Moderate Risk)
Drug recall Recall #: D-0392-2025

Dexonto 0.4%

Manufacturer / Recalling Firm: Nubratori, Inc
Reason for Recall: Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly wi...
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial).
Lots / Batch Codes & Expiration Dates
Lot #: C04292401X1, BUD: 12/25/2025 (box).
Distribution Scope
PA and CA.
Class II (Moderate Risk)
Drug recall Recall #: D-0389-2025

TIROFIBAN

Manufacturer / Recalling Firm: Eugia US LLC
Reason for Recall: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01
Lots / Batch Codes & Expiration Dates
Lot #: 3TF24002A, Exp 11/30/2026
Distribution Scope
USA nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0398-2025

NICARDIPINE HYDROCHLORIDE

Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.
Lots / Batch Codes & Expiration Dates
Lots, expiry: Lot 24025N0C0, 6/30/2025; Lot 24115N0C0, 10/31/2025; Lot 24116N0C0, 3/31/2026; Lot 24160N0C0, 12/31/2025; Lot 24217N0C0, 01/31/2026; Lot 24288N0C0, 04/30/2026; Lot 24331N0C0, 5/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0390-2025

TIROFIBAN

Manufacturer / Recalling Firm: Eugia US LLC
Reason for Recall: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01
Lots / Batch Codes & Expiration Dates
Lot# : 3TF24001, Exp 3/31/2026
Distribution Scope
USA nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0393-2025

Wegovy

Manufacturer / Recalling Firm: Cardinal Health Inc.
Reason for Recall: Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, pro...
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.
Lots / Batch Codes & Expiration Dates
Lot PZFDE06, Exp 08/31/2025
Distribution Scope
NC, SC, VA
Class II (Moderate Risk)
Drug recall Recall #: D-0396-2025

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent
FDA Report: May 07, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17
Lots / Batch Codes & Expiration Dates
Lot # D2300044, Exp Date: 12/2025
Distribution Scope
Nationwide US.

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

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