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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 1001–1020 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0543-2025

TIMOLOL MALEATE

Manufacturer / Recalling Firm: FDC Limited
Reason for Recall: Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
FDA Report: Aug 06, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Lots / Batch Codes & Expiration Dates
Lot#: 083L061, Exp.: 11/2025.
Distribution Scope
U.S Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0542-2025

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
FDA Report: Aug 06, 2025 Status: Completed Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
Lots / Batch Codes & Expiration Dates
Lot GB01616, expiration 2/28/2027
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0538-2025

PROLIA

Manufacturer / Recalling Firm: Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall: CGMP Deviations; potential temperature excursions due to transit delays
FDA Report: Jul 30, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Lots / Batch Codes & Expiration Dates
Lot: 1180924, Expiration date: 6/30/2027.
Distribution Scope
Within the U.S - OH, VA, FL.
Class II (Moderate Risk)
Drug recall Recall #: D-0540-2025

BENLYSTA

Manufacturer / Recalling Firm: Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall: CGMP Deviations; potential temperature excursions due to transit delays
FDA Report: Jul 30, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Lots / Batch Codes & Expiration Dates
Lot: YK4W, Expiration date: 4/30/2029
Distribution Scope
Within the U.S - OH, VA, FL.
Class II (Moderate Risk)
Drug recall Recall #: D-0537-2025

CLOMIPRAMINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
FDA Report: Jul 30, 2025 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Lots / Batch Codes & Expiration Dates
Lot # M300464, exp. date June, 2025
Distribution Scope
Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0535-2025

Epinephrine Lidocaine HCL

Manufacturer / Recalling Firm: Imprimis NJOF, LLC
Reason for Recall: Sub-Potent Drug: Subpotent assay results during stability testing.
FDA Report: Jul 30, 2025 Status: Completed Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
Lots / Batch Codes & Expiration Dates
Lot: 24DEC017, Exp. 07/12/2025.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0541-2025

BUDESONIDE

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
FDA Report: Jul 30, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)
Lots / Batch Codes & Expiration Dates
Batch # 4IA0505, Exp 09/31/2026
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0539-2025

EVENITY

Manufacturer / Recalling Firm: Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall: CGMP Deviations; potential temperature excursions due to transit delays
FDA Report: Jul 30, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
Lots / Batch Codes & Expiration Dates
Lot: 1178382, Expiration date: 3/31/2027
Distribution Scope
Within the U.S - OH, VA, FL.
Class III (Low Risk)
Drug recall Recall #: D-0536-2025

Tropicamide-Proparacaine-Phenylephrine-Ketorolac

Manufacturer / Recalling Firm: Imprimis NJOF, LLC
Reason for Recall: Sub-Potent Drug: Subpotent assay results during stability testing.
FDA Report: Jul 30, 2025 Status: Completed Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
Lots / Batch Codes & Expiration Dates
Lot: 25MAR032, Exp. 07/16/2025.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0521-2025

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, 100 mcg (0.1 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 16729-451-17
Lots / Batch Codes & Expiration Dates
Lot #D2300092, Exp Date: 12/31/2025; Lot #D2400722, Exp Date: 03/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0533-2025

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, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
Lots / Batch Codes & Expiration Dates
Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0550-2025

Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant

Manufacturer / Recalling Firm: A.P. Deauville, LLC
Reason for Recall: CGMP Deviations
FDA Report: Jul 23, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224
Lots / Batch Codes & Expiration Dates
Lot # 101225D781, 032926B281, 032826B221, 041126B531, 062226D011, 070626D301, 070626D333, 111026G051, 111326G091, 111626G221
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0519-2025

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), 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 16729-447-17
Lots / Batch Codes & Expiration Dates
Lot #D2400679, Exp Date: 02/28/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0549-2025

Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh

Manufacturer / Recalling Firm: A.P. Deauville, LLC
Reason for Recall: CGMP Deviations
FDA Report: Jul 23, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194
Lots / Batch Codes & Expiration Dates
Lot # 031726A991, 041226B561, 062026C901, 062026C911, 071026D351, 071026D361, 071326D391, 111626G231
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0522-2025

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, 112 mcg (0.112 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 16729-452-17
Lots / Batch Codes & Expiration Dates
Lot #D2300104, Exp Date: 12/31/2025
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0524-2025

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, 175 mcg (0.175 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 16729-456-17
Lots / Batch Codes & Expiration Dates
Lot #D2300042, Exp Date: 12/31/2025
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0520-2025

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, 50 mcg (0.05 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 16729-448-15
Lots / Batch Codes & Expiration Dates
Lot #D2300087, Exp Date: 12/31/2025
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0516-2025

LISDEXAMFETAMINE DIMESYLATE

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
FDA Report: Jul 23, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88
Lots / Batch Codes & Expiration Dates
Lot # AD42648, Exp 02/28/2026
Distribution Scope
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0548-2025

Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent

Manufacturer / Recalling Firm: A.P. Deauville, LLC
Reason for Recall: CGMP Deviations
FDA Report: Jul 23, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313
Lots / Batch Codes & Expiration Dates
Lot # 032026B011, 032226B031, 051626C241, 061526C882, 071226D371, 071226D381, 082526E341, 082826E402
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0525-2025

OMEPRAZOLE

Manufacturer / Recalling Firm: Dr. Reddy's Laboratories, Inc.
Reason for Recall: Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
FDA Report: Jul 23, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
Lots / Batch Codes & Expiration Dates
Lot: C2403017, Exp 12/31/2026
Distribution Scope
USA Nationwide

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