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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 1021–1040 of 1,170 factual FDA recall reports
Class III (Low Risk)
Drug recall Recall #: D-0517-2025

Testosterone 200 mg Pellet packaged in 1mL amber vials

Manufacturer / Recalling Firm: Qualgen, LLC
Reason for Recall: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
FDA Report: Jul 23, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01
Lots / Batch Codes & Expiration Dates
Lot number: 1043, Exp. Date 2/10/2026
Distribution Scope
Nationwide within the United States.
Class II (Moderate Risk)
Drug recall Recall #: D-0518-2025

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug: Assay below the approved specification
FDA Report: Jul 23, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15
Lots / Batch Codes & Expiration Dates
Lot #D2300325, Exp Date: 01/31/2026; Lot #D2400536, Exp Date: 02/28/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0534-2025

RIZATRIPTAN BENZOATE

Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
FDA Report: Jul 23, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18
Lots / Batch Codes & Expiration Dates
Lot 22143653, 22143675, Exp Date: July 2025; Lot 22144528, Exp Date: September 2025; Lot 22144977, Exp Date: November 2025; Lot 23140257, Exp Date: December 2025; Lot 23140999, Exp Date: Feb. 2026; Lot 23141900, 23142118, 23142120, 23142123, Exp Date: May 2026; Lot 23144563, 23144565, Exp Date: November 2026; Lot 24142623, Exp Date: May 2027; Lot...
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0530-2025

PERIPHERAL PARENTERAL NUTRITION

Manufacturer / Recalling Firm: Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
Reason for Recall: Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
FDA Report: Jul 23, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870.
Lots / Batch Codes & Expiration Dates
Lot: a) 11-4785290-0-1, BUD: 6/19/2025 @ 11:32 pm; b) 11-4785217-0-1, BUD: 6/19/2025 @ 10:25 pm.
Distribution Scope
CA
Class II (Moderate Risk)
Drug recall Recall #: D-0523-2025

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug: Assay below the approved specification
FDA Report: Jul 23, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17
Lots / Batch Codes & Expiration Dates
Lot #D2300076, Exp Date: 12/31/2025
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0532-2025

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir t...
FDA Report: Jul 23, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
Lots / Batch Codes & Expiration Dates
Lot #: QA01081, Exp. Date April 2027
Distribution Scope
Product was distributed nationwide within the United States.
Class II (Moderate Risk)
Drug recall Recall #: D-0515-2025

In Your Face Mineral Tint SPF 31

Manufacturer / Recalling Firm: KABANA SKIN CARE
Reason for Recall: cGMP deviations
FDA Report: Jul 16, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL - 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin Care, Belleair Bluffs, FL, Made in USA, NDC: 73369-1601-1
Lots / Batch Codes & Expiration Dates
Lot: 408-002
Distribution Scope
NJ, FL, MI
Class II (Moderate Risk)
Drug recall Recall #: D-0512-2025

B Natural Organics

Manufacturer / Recalling Firm: KABANA SKIN CARE
Reason for Recall: cGMP deviations
FDA Report: Jul 16, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c) Tan Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1003-2.
Lots / Batch Codes & Expiration Dates
Lots: a) 410-001, Exp 10/31/2027 b) 404-003, Exp 04/30/2027 c) 404-001, Exp 04/30/2027
Distribution Scope
NJ, FL, MI
Class II (Moderate Risk)
Drug recall Recall #: D-0511-2025

DULOXETINE

Manufacturer / Recalling Firm: Breckenridge Pharmaceutical, Inc.
Reason for Recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
FDA Report: Jul 16, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
Lots / Batch Codes & Expiration Dates
Lot # 230199, Exp. Date 01/31/2026
Distribution Scope
U.S. Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0509-2025

FAMCICLOVIR

Manufacturer / Recalling Firm: Macleods Pharmaceuticals Ltd
Reason for Recall: Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
FDA Report: Jul 16, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.
Lots / Batch Codes & Expiration Dates
Lot # 12250247B, Exp. 01/31/2027
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0513-2025

Erin's Faces

Manufacturer / Recalling Firm: KABANA SKIN CARE
Reason for Recall: cGMP deviations
FDA Report: Jul 16, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1
Lots / Batch Codes & Expiration Dates
Lot: 410-002
Distribution Scope
NJ, FL, MI
Class II (Moderate Risk)
Drug recall Recall #: D-0514-2025

GreenScreen

Manufacturer / Recalling Firm: KABANA SKIN CARE
Reason for Recall: cGMP deviations
FDA Report: Jul 16, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1
Lots / Batch Codes & Expiration Dates
Lots: 405-002 and 405-003
Distribution Scope
NJ, FL, MI
Class II (Moderate Risk)
Drug recall Recall #: D-0508-2025

GABAPENTIN

Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Defective container; blister packaging inadequately sealed.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
Lots / Batch Codes & Expiration Dates
Lot# M05205A and M05205B, Exp Date 10/2026.
Distribution Scope
Nationwide
Class I (High Risk)
Drug recall Recall #: D-0505-2025

ZICAM NASAL ALLCLEAR

Manufacturer / Recalling Firm: Church & Dwight Inc
Reason for Recall: Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
Lots / Batch Codes & Expiration Dates
All Lots.
Distribution Scope
Nationwide in the USA.
Class III (Low Risk)
Drug recall Recall #: D-0526-2025

PITAVASTATIN

Manufacturer / Recalling Firm: Orient Pharma Co., Ltd. Yunlin Plant
Reason for Recall: Failed Impurities/Degradation Specifications.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98.
Lots / Batch Codes & Expiration Dates
P061001, P061002, P061003, P061004, P061006 & P061007 Exp Date 07/2025; P061008, Exp Date 08/2025; P061009 & P061010 Exp Date 10/2025; P061011, P061012 & P061013 Exp Date 01/2026; P061016, P061017 & P061018, Exp Date 04/2026; P061019, Exp Date 05/2026; P061023, Exp Date 01/2027.
Distribution Scope
NJ
Class II (Moderate Risk)
Drug recall Recall #: D-0503-2025

LIDOcaine HCL Sterile Injection

Manufacturer / Recalling Firm: Tailstorm Health INC
Reason for Recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
Lots / Batch Codes & Expiration Dates
Lot #: 2504003, Exp. 04/03/2027
Distribution Scope
Nationwide in the US
Class III (Low Risk)
Drug recall Recall #: D-0529-2025

PITAVASTATIN

Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Failed Impurity/Degradation Specifications
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0510-2025

METOPROLOL SUCCINATE

Manufacturer / Recalling Firm: Granules Pharmaceuticals Inc.
Reason for Recall: Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,
Lots / Batch Codes & Expiration Dates
Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0498-2025

LIDOcaine HCl Injection

Manufacturer / Recalling Firm: Tailstorm Health INC
Reason for Recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0000-0.
Lots / Batch Codes & Expiration Dates
Lot #s: 2502004, Exp. 2/18/27; 2503003, Exp. 3/19/27
Distribution Scope
Nationwide in the US
Class I (High Risk)
Drug recall Recall #: D-0504-2025

ZICAM COLD REMEDY MEDICATED NASAL SWABS

Manufacturer / Recalling Firm: Church & Dwight Inc
Reason for Recall: Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
Lots / Batch Codes & Expiration Dates
All lots.
Distribution Scope
Nationwide 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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