Home
Disease Vault Drug Index & Alternatives Drug Interactions Pregnancy Drug Safety Drug Recalls & Alerts OTC Navigator
Medical Bot Med Lab Clinical Cases Nutrition & Macro Calculator
Questo Insights Global Opportunities Paper Helper Citation Generator Scholarships & Travel Visa & Mobility Navigator English Assessment Test
Med Jobs Med Lounge Pharma Swap Pharmacies Directory Medical Case Donations Opportunity Crowdfunding
Courses Academy Quiz Arena Memory Palace STEM Academy Toolkits
About Us Contact Us Privacy Policy Terms of Service
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
6 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 1–20 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0854-2026

MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++

Manufacturer / Recalling Firm: SHANTOU Qiwei industrial Co., Ltd
Reason for Recall: cGMP Deviations
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guangdong Province, China
Lots / Batch Codes & Expiration Dates
Lot #: 2024/10/11, Exp. Date 10/10/2027
Distribution Scope
CA only
Class II (Moderate Risk)
Drug recall Recall #: D-0859-2026

LUBRICATING TEARS

Manufacturer / Recalling Firm: Sterling Pharmaceutical Services LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55.
Lots / Batch Codes & Expiration Dates
Lot # 3171, Expiration Date 09/30/2026. Lot # 3174, Expiration Date 10/31/2026; Lot #3275, Expiration Date, 06/30/2027; Lot #3304, Expiration date 07/31/2027.
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0870-2026

Clear Eyes Redness Relief

Manufacturer / Recalling Firm: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15
Lots / Batch Codes & Expiration Dates
Lot #: RL25G02, RL25G03, RL25G04, Exp. Date Jul-27; RL25H02, RL25H03, RL25H04, Exp. Date Aug-27; RL25K01, RL25K02, RL25K03, RL25K04, Exp. Date Sep-27; RL25M01, RL25M02, RL25M03, RL25M04, Exp. Date Oct-27; RL25N01, RL25N02, RL25N04, Exp. Date Nov-27.
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0857-2026

WALGREENS LUBRICANT EYE DROPS

Manufacturer / Recalling Firm: Sterling Pharmaceutical Services LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8833-15.
Lots / Batch Codes & Expiration Dates
Lot # 3166, Expiry: 9/2026; Lot # 3172, Expiry: 9/2026; Lot # 3173, Expiry: 9/2026; Lot # 3175, Expiry: 10/2026; Lot # 3176, Expiry: 10/2026; Lot # 3177, Expiry: 10/2026; Lot # 3178, Expiry:10/2026; Lot # 3180, Expiry: 11/2026; Lot # 3188, Expiry: 12/2026; Lot # 3202, Expiry: 12/2026; Lot # 3203, Expiry: 12/2026; Lot # 3205, Expiry: 12/2026; Lot #...
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0861-2026

Major LubriFresh P.M. Nighttime Ointment

Manufacturer / Recalling Firm: Sterling Pharmaceutical Services LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38
Lots / Batch Codes & Expiration Dates
Lot # 3183
Distribution Scope
USA Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0867-2026

OLANZAPINE

Manufacturer / Recalling Firm: Macleods Pharmaceuticals Limited
Reason for Recall: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.
Lots / Batch Codes & Expiration Dates
Lot: BOB22321A, Exp 07-31-2027.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0868-2026

EXENATIDE

Manufacturer / Recalling Firm: Amneal Pharmaceuticals of New York, LLC
Reason for Recall: Defective Delivery System: Possibility of no medication in the prefilled pen.
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1
Lots / Batch Codes & Expiration Dates
Lot #: AP250095A, Exp 2/28/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0858-2026

WALGREENS LUBRICANT EYE DROPS

Manufacturer / Recalling Firm: Sterling Pharmaceutical Services LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15.
Lots / Batch Codes & Expiration Dates
Lot # 3165, Expiry: 9/2026; Lot # 3179, Expiry: 10/2026; Lot # 3204, Expiry: 12/2026; Lot #3206, Expiry: 12/2026, Lot # 3208, Expiry: 12/2026; Lot #3259, Expiry: 4/2027; Lot #: 3265, Expiry: 5/2027; Lot # 3268; Expiry 6/2027; Lot #3272, Expiry: 5/2027; Lot # 3273, Expiry: 6/2027; Lot #3276, Expiry: 6/2027; Lot # 3278, Expiry: 6/2027; Lot # 3280, E...
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0856-2026

SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%

Manufacturer / Recalling Firm: Sterling Pharmaceutical Services LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55.
Lots / Batch Codes & Expiration Dates
Lot #3192, Exp Date 01/312027; 3293, 3336 Exp Date 06/30/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0862-2026

Lubricant Eye Drops-Cameron Pharmaceuticals

Manufacturer / Recalling Firm: Sterling Pharmaceutical Services LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05
Lots / Batch Codes & Expiration Dates
Lot # 3163, Expiry: 8/31/2026; Lot# 3164, Expiry: 9/30/2026.
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0855-2026

CARBOXYMETHYLCELLULOSE SODIUM

Manufacturer / Recalling Firm: Sterling Pharmaceutical Services LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15
Lots / Batch Codes & Expiration Dates
Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0871-2026

Clear Eyes Redness Relief

Manufacturer / Recalling Firm: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15
Lots / Batch Codes & Expiration Dates
Lot #: RL25G04, Exp. Date 07/2027; RL2H02, Exp. Date 08/2027.
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0863-2026

CARBOXYMETHYLCELLULOSE SODIUM

Manufacturer / Recalling Firm: Sterling Pharmaceutical Services LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton)
Lots / Batch Codes & Expiration Dates
Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0860-2026

GENTLE EYES LUBRICANT EYE DROPS

Manufacturer / Recalling Firm: Sterling Pharmaceutical Services LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Sep 30, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci Ln, Reno, NV 89502, NDC 17312-430-15.
Lots / Batch Codes & Expiration Dates
Lot # 3279, Exp 6/30/2027; Lot # 3292, Exp 5/31/2027.
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0853-2026

DOPAMINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Pfizer
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Sep 23, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.
Lots / Batch Codes & Expiration Dates
Lot # NL5230, Exp Date:10/2027
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0852-2026

CHLORTHALIDONE

Manufacturer / Recalling Firm: Inventia Healthcare Limited
Reason for Recall: Failed Dissolution Specifications
FDA Report: Sep 23, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01
Lots / Batch Codes & Expiration Dates
Batch # RISA24002; Exp Date: 04/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0848-2026

LIDOCAINE

Manufacturer / Recalling Firm: SUN PHARMA /TARO
Reason for Recall: Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
FDA Report: Sep 23, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5
Lots / Batch Codes & Expiration Dates
Lot # AD48154, Exp: 4/30/2027.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0841-2026

Fluphenazine HCl Elixir

Manufacturer / Recalling Firm: Safecor Health, LLC
Reason for Recall: Failed Stability Specifications
FDA Report: Sep 23, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
Lots / Batch Codes & Expiration Dates
Lot#26160463; Exp :04/20/2027 Lot#25430188; Exp :11/26/2026 Lot#25440715; Exp :12/9/2026 Lot#25501160; Exp :01/21/2027 Lot#26021054; Exp :02/5/2027 Lot#26130635; Exp :04/3/2027 Lot#26200964; Exp :05/13/2027
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0842-2026

Fluphenazine HCl Elixir

Manufacturer / Recalling Firm: Safecor Health, LLC
Reason for Recall: Failed Stability Specifications
FDA Report: Sep 23, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
Lots / Batch Codes & Expiration Dates
Lot #:25330169; Exp :08/25/2026 Lot #:25340107; Exp :09/04/2026 Lot #:25370044; Exp :09/30/2026 Lot #:25391430; Exp :10/30/2026 Lot #:25411035; Exp :11/13/2026 Lot #:25461036; Exp :12/12/2026 Lot #:25450206; Exp :12/12/2026 Lot #:25521269; Exp :02/03/2027 Lot #:26030426; Exp :02/09/2027 Lot #:26071765; Exp :03/11/2027 Lot #:26111371; Exp...
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0843-2026

Fluphenazine HCl Elixir

Manufacturer / Recalling Firm: Safecor Health, LLC
Reason for Recall: Failed Stability Specifications
FDA Report: Sep 23, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
Lots / Batch Codes & Expiration Dates
Lot#:26220866; Exp :06/18/2027 Lot#:25321477; Exp :0/18/2026 Lot#:25471651; Exp :12/01/2026 Lot#:25500133; Exp :12/19/2026 Lot#:26161398; Exp :12/31/2026 Lot#:26170946; Exp :05/15/2027 Lot#:26240033; Exp :05/31/2027
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

Confirm Action