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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 101–120 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0799-2026

MULTRYS

Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
FDA Report: Aug 26, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Lots / Batch Codes & Expiration Dates
Lot #: 25163, Exp. Date: 4/30/2027.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0771-2026

CARBAMAZEPINE

Manufacturer / Recalling Firm: Golden State Medical Supply Inc.
Reason for Recall: CGMP deviations: tablets with black specks.
FDA Report: Aug 26, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed by: GSMS, Incorporated, Camarillo, CA 93012 USA
Lots / Batch Codes & Expiration Dates
Lot #: a) GS067429, GS068091, Exp 5/31/2028; b) GS067430, GS068090, Exp 5/31/2028
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0793-2026

CYANOCOBALAMIN

Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
FDA Report: Aug 26, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Lots / Batch Codes & Expiration Dates
Lot #: 25082, Exp. Date: 3/31/2027.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0762-2026

TADALAFIL USP

Manufacturer / Recalling Firm: Shoolin Pharma Chem LLP
Reason for Recall: CGMP Deviations:Noted during FDA inspection
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08
Lots / Batch Codes & Expiration Dates
Batch TLF2506001, Date of Expiry: May 31, 2028.
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0763-2026

SILDENAFIL CITRATE USP

Manufacturer / Recalling Firm: Shoolin Pharma Chem LLP
Reason for Recall: CGMP Deviations:Noted during FDA inspection
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.
Lots / Batch Codes & Expiration Dates
Lot: SDC2505001, Date of Expiry: April 30, 2030.
Distribution Scope
Distributed Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0787-2026

Cefazolin in Dextrose

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: Presence of Particulate Matter
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.
Lots / Batch Codes & Expiration Dates
Lot # LD175708, Exp Date: 14-Feb-2027.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0754-2026

SEMAGLUTIDE 5mg

Manufacturer / Recalling Firm: Apollo Care, LLC
Reason for Recall: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03
Lots / Batch Codes & Expiration Dates
Lot: AC-017272, Exp. 12/12/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0746-2026

DIOVAN

Manufacturer / Recalling Firm: Novartis Pharmaceuticals Corporation
Reason for Recall: Failed Dissolution Specifications
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
Lots / Batch Codes & Expiration Dates
Lot AV5913C, Expiry: 6/2027
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0750-2026

SEMAGLUTIDE 4.5mg

Manufacturer / Recalling Firm: Apollo Care, LLC
Reason for Recall: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03
Lots / Batch Codes & Expiration Dates
Lot: AC-017124, Exp. 8/30/2026; AC-017136, Exp. 12/31/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0761-2026

TADALAFIL USP

Manufacturer / Recalling Firm: Shoolin Pharma Chem LLP
Reason for Recall: CGMP Deviations:Noted during FDA inspection
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.
Lots / Batch Codes & Expiration Dates
Batch TLF2506001, Date of Expiry: May 31, 2028.
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0760-2026

TADALAFIL USP

Manufacturer / Recalling Firm: Shoolin Pharma Chem LLP
Reason for Recall: CGMP Deviations:Noted during FDA inspection
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.
Lots / Batch Codes & Expiration Dates
Lot: TLF2506001, Date of Expiry: May 31, 2028.
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0751-2026

SEMAGLUTIDE 9mg

Manufacturer / Recalling Firm: Apollo Care, LLC
Reason for Recall: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02
Lots / Batch Codes & Expiration Dates
Lot: AC-017125, Exp. 8/30/2026; AC-017138, AC-017147, AC-017214, AC-017226, AC-017228, Exp. 12/31/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0756-2026

SEMAGLUTIDE 10mg

Manufacturer / Recalling Firm: Apollo Care, LLC
Reason for Recall: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02
Lots / Batch Codes & Expiration Dates
Lot: AC-017274, Exp. 12/12/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0757-2026

SEMAGLUTIDE 20mg

Manufacturer / Recalling Firm: Apollo Care, LLC
Reason for Recall: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04.
Lots / Batch Codes & Expiration Dates
Lot: AC-017275, Exp. 12/13/2026; AC-017282, AC-017285, Exp. 12/27/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0766-2026

CLEAR EYES Maximum Itchy Eye Relief

Manufacturer / Recalling Firm: Prestige Brands Holdings
Reason for Recall: Lack of assurance of sterility. The recall is due to potential contamination
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
Lots / Batch Codes & Expiration Dates
Lot 2552A, Exp 09/30/2027
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0752-2026

SEMAGLUTIDE 0.9mg

Manufacturer / Recalling Firm: Apollo Care, LLC
Reason for Recall: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01
Lots / Batch Codes & Expiration Dates
Lot: AC-017131, Exp. 8/30/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0749-2026

SEMAGLUTIDE 6.75mg

Manufacturer / Recalling Firm: Apollo Care, LLC
Reason for Recall: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01
Lots / Batch Codes & Expiration Dates
Lot: C-017115, Exp. 11/25/2026; AC-017163, Exp. 12/31/2026; AC-017169, AC-017170, AC-017171, Exp. 12/31/2026; AC-017230, AC-017231, Exp. 5/5/2027.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0753-2026

SEMAGLUTIDE 2.5mg

Manufacturer / Recalling Firm: Apollo Care, LLC
Reason for Recall: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02
Lots / Batch Codes & Expiration Dates
Lot: AC-017271, Exp. 12/12/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0768-2026

CLINDAMYCIN PALMITATE HYDROCHLORIDE

Manufacturer / Recalling Firm: Heritage Pharmaceuticals Inc
Reason for Recall: Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
Lots / Batch Codes & Expiration Dates
Lot #: 2411550, Exp. 2026/NOV.
Distribution Scope
Nationwide within the U.S
Class I (High Risk)
Drug recall Recall #: D-0773-2026

OPTIRAY

Manufacturer / Recalling Firm: Liebel-Flarsheim Company LLC
Reason for Recall: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
FDA Report: Aug 19, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.
Lots / Batch Codes & Expiration Dates
Lot # 25ZF3670, Exp Date: May 31, 2027.
Distribution Scope
Distributed Nationwide in the US and Mexico.

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