Home
Disease Knowledge Center Drug Hub Monographs Drug Interactions Pregnancy Drug Safety Drug Recalls & Alerts OTC Navigator
Virtual Simulators Hub Clinical Cases Simulator Nutrition & Macro Calculator
Questo Insights Global Opportunities Hub AI Research Assistant Citation & Reference Generator Scholarships & Essay Planner Visa & Mobility Navigator English Assessment Test
Verified Jobs Board Pharmacy Clearance Pharmacies Directory
Practice Quizzes STEM Academy Toolkits
Medical Case Donations Opportunity Crowdfunding Community Forums Courses Academy
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
2 weeks ago
Total FDA Recalls
999
Active / Ongoing
962
Critical (Class I)
45
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
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinib...
Blaine Labs Inc Jul 08, 2026
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Ste...
CareFusion 213, LLC Jul 01, 2026
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides.
CareFusion 213, LLC Jul 01, 2026
Showing 301–320 of 999 factual FDA recall reports
Class III (Low Risk)
Drug recall Recall #: D-0391-2026

PITAVASTATIN CALCIUM

Manufacturer / Recalling Firm: Annora Pharma Private Limited
Reason for Recall: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
FDA Report: Mar 25, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.
Lots / Batch Codes & Expiration Dates
Lot #: A252487, Exp 05/31/2027
Distribution Scope
TN
Class II (Moderate Risk)
Drug recall Recall #: D-0390-2026

IBUPROFEN

Manufacturer / Recalling Firm: STRIDES PHARMA INC
Reason for Recall: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
FDA Report: Mar 25, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
Lots / Batch Codes & Expiration Dates
Lot: 7261973A, 7261974A, Exp 01/31/2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0407-2026

BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION

Manufacturer / Recalling Firm: Apotex Corp.
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Mar 25, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.
Lots / Batch Codes & Expiration Dates
Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0400-2026

ICOSAPENT ETHYL

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
FDA Report: Mar 18, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Lots / Batch Codes & Expiration Dates
Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0388-2026

SILINTAN 25/pills

Manufacturer / Recalling Firm: ANTHONY TRINH, 123Herbals LLC
Reason for Recall: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
USA nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0377-2026

Children's Healthcare of Atlanta

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00
Lots / Batch Codes & Expiration Dates
Lot #: MN12122, Exp. Date Apr 2027; MN27523, Exp. Date Aug 2028; MN30922, Exp. Date Oct 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0356-2026

METOPROLOL SUCCINATE

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Failed Dissolution Specifications
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.
Lots / Batch Codes & Expiration Dates
Lot#: a) 0718J251, 0729J251, 0730J251, Exp.: 12/2026; b) 0718J252, 0729J252, 0730J252, Exp.: 12/2026.
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0362-2026

1) BZK Antiseptic Towelettes

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1000 ea Bulk, Made in USA for : Food Service Resources, Flowery Branch, GA 30542. NDC 0924-7130-00. 3) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Wellstar Cobb Hand Wipes, 1000 ea Bulk, Made in the USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 4) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" FSR Sanitizing Hand Wipes, 1000 ea Bulk, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. Inner Packaging - Instant Hand Sanitizing Wipes 5) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x7" Children's 1000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542 NDC 0924-713-00. Inner packaging -Children's Healthcare of Atlanta
Lots / Batch Codes & Expiration Dates
1) Lot #: MN22222, Exp. Date Jul 2027; MN05523, Exp. Date Jan 2028; MN32023, Exp. Date Oct 2028; MN15523, Exp. Date May 2028. 2) Lots MN11422B, MN11422, Exp. Date Mar 2027; MN03823, Exp. Date Jan 2028; MN09223 Exp. Date Mar 2028; MN32123, Exp. Date Oct 2028; MN20323, Exp. Date Jun 2028; MN30822 Exp. Date Oct 2027; MN304024, Exp. Date Dec 2028; M...
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0372-2026

WP WipesPlus Hand Sanitizing Wipes

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.
Lots / Batch Codes & Expiration Dates
Lot #: MN27922, MN21722, MN21822, Exp. Date Jul 2027; MN27422, MN27522, Exp. Date Sep 2027; MN25422, Exp. Date Aug 2027; MN27922, MN27922, Exp. Date Sep 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0370-2026

MED NAP CLEANSING TOWELETTE

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.
Lots / Batch Codes & Expiration Dates
Lot #: MN15923, Exp. Date May 2028; MN25822, Exp. Date Aug 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0357-2026

METOPROLOL SUCCINATE

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Failed Dissolution Specifications
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11
Lots / Batch Codes & Expiration Dates
Lot#: a) 0686H251, 0687H251, 10688H251, Exp.: 02/2027. .
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0374-2026

GREEN GUARD ANTISEPTIC WIPES

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73
Lots / Batch Codes & Expiration Dates
Lot #: MN15922, Exp. Date Apr 2027; MN18223, Exp. Date May 2028; MN10123, Exp. Date Mar 2028; MN27223, Exp. Date Aug 2028; MN01023, Exp. Date Dec 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0354-2026

METOPROLOL SUCCINATE

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Failed Dissolution Specifications
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
Lots / Batch Codes & Expiration Dates
Lot#: a) 0715J251, Exp.: 12/2026; 0716J251, Exp.: 01/2027; 0717J251, Exp.: 01/2027; b) 0715J252, Exp.: 12/2026; 0716J252, Exp.: 01/2027, 0717J252, Exp.: 01/2027.
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0389-2026

SODIUM IODIDE I-131

Manufacturer / Recalling Firm: Radnostix
Reason for Recall: Presence of Particulate Matter: Due to production issues
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
Lots / Batch Codes & Expiration Dates
Batch I012626R-01, Exp 02/09/2026
Distribution Scope
Nationwide in the USA and Puerto Rico
Class II (Moderate Risk)
Drug recall Recall #: D-0399-2026

AMNESTEEM

Manufacturer / Recalling Firm: MYLAN PHARMACEUTICALS INC
Reason for Recall: Failed Dissolution Specifications
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
Lots / Batch Codes & Expiration Dates
Lot #: 3116110, 3116130, Exp. Date 07/2026
Distribution Scope
Nationwide within the United States
Class I (High Risk)
Drug recall Recall #: D-0397-2026

MR. 7 SUPER 700000 capsules

Manufacturer / Recalling Firm: StuffbyNainax
Reason for Recall: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Lots / Batch Codes & Expiration Dates
All codes; Exp 12/31/2029
Distribution Scope
Product was distributed to 4 customers in the US.
Class III (Low Risk)
Drug recall Recall #: D-0382-2026

NILOTINIB

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17
Lots / Batch Codes & Expiration Dates
Lot #: 5GJ0223, Exp 04/30/2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0379-2026

Semaglutide

Manufacturer / Recalling Firm: Harbin Jixianglong Biotech Co., Ltd.
Reason for Recall: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China
Lots / Batch Codes & Expiration Dates
Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0360-2026

BZK TOWELETTE

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1
Lots / Batch Codes & Expiration Dates
Lot #: MN31621, Exp. Date Oct 2026; MN14522, MN15522, Exp. Date Apr 2027; MN28122, MN31522, Exp. Date Sept 2027; MN04223, MN06023, Exp. Date Feb 2028; MN17223, Exp. Date May 2028; MN25123, Exp Date Aug 2028; MN33123, MN33523, Exp. Date Nov 2028.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0365-2026

MEDI-FIRST ANTISEPTIC WIPES

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33.
Lots / Batch Codes & Expiration Dates
Lot #: MN15922, Exp. Date Apr 2027; MN31022, Exp. Date Oct 2027; MN27223, Exp. Date 2028-Aug.
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