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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 141–160 of 1,170 factual FDA recall reports
Class III (Low Risk)
Drug recall Recall #: D-0735-2026

DABIGATRAN ETEXILATE

Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.
Lots / Batch Codes & Expiration Dates
Lot: 25141707, Exp 4/30/2027.
Distribution Scope
USA Nationwide
Class I (High Risk)
Drug recall Recall #: D-0732-2026

CETIRIZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: JB Chemicals and Pharmaceuticals Ltd
Reason for Recall: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, 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 16571-401-10.
Lots / Batch Codes & Expiration Dates
Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0724-2026

CYPROHEPTADINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Rising Pharma Holding, Inc.
Reason for Recall: Presence of Precipitate: medication was crystallizing and particles floating in the bottle
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.
Lots / Batch Codes & Expiration Dates
Lots: Batch # CR2518, Exp. 11/2027; Batch # CR2601, Exp. 12/2027; CR2602, CR2603, Exp. 01/2028; CR2604, CR2605, Exp. 02/2028.
Distribution Scope
Nationwide U.S.A.
Class II (Moderate Risk)
Drug recall Recall #: D-0708-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Major Pharmaceuticals
Reason for Recall: Subpotent Drug
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61
Lots / Batch Codes & Expiration Dates
Bag lot #: N02200A, N02200B, Exp. Date 10/2026; Blister lot #: N02200, Exp. Date 10/2026
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0741-2026

GLYCOPYRROLATE

Manufacturer / Recalling Firm: Precision Dose Inc.
Reason for Recall: Failed Impurities/Degradation Specifications
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).
Lots / Batch Codes & Expiration Dates
Lot # 506033, Exp Date: 11/30/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0705-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Major Pharmaceuticals
Reason for Recall: Subpotent Drug
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61
Lots / Batch Codes & Expiration Dates
Lot #: N02266, Exp. Date 11/2026
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0725-2026

GLYCOPYRROLATE

Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Presence of Particulate Matter: Hair was found in product
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
Lots / Batch Codes & Expiration Dates
Lot #: 6134349, 6134620 Exp. Date 11/2026
Distribution Scope
Nationwide within in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0729-2026

XYLOCAINE

Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Presence of Particulate Matter: Hair was found in products
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03
Lots / Batch Codes & Expiration Dates
Lot #: 6133986, Exp. Date 02/2029
Distribution Scope
Nationwide within in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0718-2026

ROHTO OPTIC GLOW

Manufacturer / Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
Lots / Batch Codes & Expiration Dates
Lot #: 3H1V, 3H1VA, Exp. Date 2025/07; 3J1V, 3J2V, Exp. Date 2025/09; 3K1V, Exp. Date 2025/10; 4F1V, Exp. Date 2027/05; 4F1VA, Exp. Date 2027/05; 4H1V, Exp. Date 2027/07; 4I1V, Exp. Date 2027/08; 4K1V, 4K2V,Exp. Date 2027/10; 5A1V, 5A2V, Exp. Date 2027/12; 5D1V, Exp. Date 2028/03; 5E1V, Exp. Date2028/04; 5J1V, 5J2V, Exp. Date 2028/09; 6B1V, Exp. D...
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0704-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Major Pharmaceuticals
Reason for Recall: Subpotent Drug
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61
Lots / Batch Codes & Expiration Dates
Lot #: N02203, Exp. Date 09/2026
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0707-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Major Pharmaceuticals
Reason for Recall: Subpotent Drug
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61
Lots / Batch Codes & Expiration Dates
Bag lot #: N02212A, N02212B, Exp. Date 07/2026; Blister lot #: N02212, Exp. Date 07/2026
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0712-2026

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
Lots / Batch Codes & Expiration Dates
Lot 25121311, expiry 3/31/2028
Distribution Scope
Nationwide in the USA
Class III (Low Risk)
Drug recall Recall #: D-0713-2026

LIDOLOG KIT

Manufacturer / Recalling Firm: Asclemed USA Inc.
Reason for Recall: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01.
Lots / Batch Codes & Expiration Dates
Lot: 070126X1, Exp. 12/31/2027.
Distribution Scope
Within U.S. - Tennessee
Class II (Moderate Risk)
Drug recall Recall #: D-0742-2026

DIVALPROEX SODIUM

Manufacturer / Recalling Firm: Bionpharma Inc.
Reason for Recall: Presence of Foreign Tablets/Capsules
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.
Lots / Batch Codes & Expiration Dates
Lot# 704C003, Exp. 12/31/2028
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0717-2026

ROHTO

Manufacturer / Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
Lots / Batch Codes & Expiration Dates
Lot #: 3H1V, Exp. Date2026/07; 3J2V, Exp. Date 2026/09; 4A1V, 4A1VA, Exp. Date 2026/12; 4G1V, Exp. Date 2027/06; 4I3V, Exp. Date 2027/08; 5A1V, Exp. Date 2027/12; 5B3V, Exp. Date2028/01; 5G3V, Exp. Date 2028/06; 5J1V, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6A1V, Exp. Date 2028/12; 6B4V, Exp. Date 2029/01; 6C2V, Exp. Date 2029/02.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0726-2026

LIDOCAINE

Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Presence of Particulate Matter: Hair was found in products
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01
Lots / Batch Codes & Expiration Dates
Lot #: 6133801, Exp. Date 01/2028
Distribution Scope
Nationwide within in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0701-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Major Pharmaceuticals
Reason for Recall: Subpotent Drug
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61
Lots / Batch Codes & Expiration Dates
Lot #: N02200, Exp. Date 10/2026
Distribution Scope
Nationwide in the USA.
Class III (Low Risk)
Drug recall Recall #: D-0736-2026

DABIGATRAN ETEXILATE

Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.
Lots / Batch Codes & Expiration Dates
Lot: 25141584, Exp 4/30/2027.
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0720-2026

ROHTO DRY-AID

Manufacturer / Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1
Lots / Batch Codes & Expiration Dates
Lot #: 4G1VA, Exp. Date 2027/06; 4J1VA, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12; 5D1VA, Exp. Date 2028/03; 5G1VA, Exp. Date 2028/06; 512V, 512V, 512VB Exp. Date 2028/08; 5L2VA, 512VB 2028/11.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0728-2026

XYLOCAINE

Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Presence of Particulate Matter: Hair was found in products
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
Lots / Batch Codes & Expiration Dates
Lot #: 6130235, Exp. Date 02/2027
Distribution Scope
Nationwide within in the USA

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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