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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
10 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 981–1000 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0560-2025

Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol

Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall Recall #: D-0572-2025

XOLAIR

Manufacturer / Recalling Firm: Cardinal Health Inc.
Reason for Recall: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Lots / Batch Codes & Expiration Dates
Lot: 3630004, Expires: 10/31/2025.
Distribution Scope
Nationwide Within the U.S.
Class II (Moderate Risk)
Drug recall Recall #: D-0561-2025

Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol

Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall Recall #: D-0566-2025

DOXEPIN HYDROCHLORIDE

Manufacturer / Recalling Firm: Alembic Pharmaceuticals Limited
Reason for Recall: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31
Lots / Batch Codes & Expiration Dates
Lot: 2305015142, Exp. Date: 9/30/2025
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0558-2025

Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol

Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall Recall #: D-0573-2025

RECOMBINATE

Manufacturer / Recalling Firm: Cardinal Health Inc.
Reason for Recall: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Lots / Batch Codes & Expiration Dates
Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025
Distribution Scope
Nationwide Within the U.S.
Class II (Moderate Risk)
Drug recall Recall #: D-0554-2025

Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol

Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall Recall #: D-0574-2025

SPIRONOLACTONE

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Presence of foreign substance: identified as aluminum.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01
Lots / Batch Codes & Expiration Dates
Lot # P3314, Exp 11/30/2026
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0553-2025

Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol

Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall Recall #: D-0555-2025

Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol

Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall Recall #: D-0562-2025

Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol

Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall Recall #: D-0567-2025

Duloxetine D/R

Manufacturer / Recalling Firm: Direct Rx
Reason for Recall: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
Lots / Batch Codes & Expiration Dates
Lot #: 02AU2406, Exp 01/31/2027
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0564-2025

Semaglutide + Cyanocobalamin injection solution

Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall Recall #: D-0563-2025

Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol

Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall Recall #: D-0552-2025

DULOXETINE

Manufacturer / Recalling Firm: Breckenridge Pharmaceutical, Inc.
Reason for Recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
FDA Report: Aug 13, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
Lots / Batch Codes & Expiration Dates
Lot: 230836C, Exp.: 02/28/2026
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0546-2025

CINACALCET

Manufacturer / Recalling Firm: Strides Pharma, Inc.
Reason for Recall: Failed Dissolution Specifications.
FDA Report: Aug 06, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
Lots / Batch Codes & Expiration Dates
Lot #: 7715893A, Exp. Date 12/31/2027
Distribution Scope
Product was distributed nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0545-2025

BICILLIN L-A

Manufacturer / Recalling Firm: Pfizer Inc.
Reason for Recall: CGMP Deviations; particulates identified during visual inspection
FDA Report: Aug 06, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04
Lots / Batch Codes & Expiration Dates
Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0551-2025

LORAZEPAM

Manufacturer / Recalling Firm: Hikma Pharmaceuticals USA Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
FDA Report: Aug 06, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Lots / Batch Codes & Expiration Dates
Lot # K24118, exp. date 10/31/2026
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0544-2025

BICILLIN L-A

Manufacturer / Recalling Firm: Pfizer Inc.
Reason for Recall: CGMP Deviations; particulates identified during visual inspection
FDA Report: Aug 06, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02
Lots / Batch Codes & Expiration Dates
Lots: HJ3235, Exp 09/30/26; GL2954, HP6222, Exp, 01/31/27; HR9967, Exp 05/31/27; HP6232, LT5190,Exp 09/30/27; HP6228, Exp 10/31/27;
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0547-2025

Sucralfate Tablets

Manufacturer / Recalling Firm: Nostrum Laboratories, Inc.
Reason for Recall: CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity charac...
FDA Report: Aug 06, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
Lots / Batch Codes & Expiration Dates
All Lots within expiry dates.
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