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 hours ago

Total FDA Recalls

1,216

Active / Ongoing

1,179

Critical (Class I)

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

Tri-Immune Boost

Microbial Contamination of Sterile Products - out of specifications results were obtained...

Centric Compounding LLC Oct 14, 2026

Class I

THYROID

Superpotent Drug

VITRUVIAS THERAPEUTICS INC 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 1,216 factual FDA recall reports

Class II (Moderate Risk)

Drug recall Recall #: D-0040-2027

Tirzepatide/Niacinamide 2mL vial

Manufacturer / Recalling Firm: Houston Rx LLC

Reason for Recall: Lack of assurance of sterility.

FDA Report: Oct 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.

Lots / Batch Codes & Expiration Dates

Lot# TZN-080326-20/2-2, Beyond Use Date: 12/01/2026.

Distribution Scope

Nationwide in the USA.

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0039-2027

HYDROCORTISONE SODIUM SUCCINATE

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc

Reason for Recall: Failed Impurities/Degradation Specifications.

FDA Report: Oct 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1.

Lots / Batch Codes & Expiration Dates

Lot #: LB00047A, LB00048A, Exp. Date 03/2028

Distribution Scope

Nationwide within the United States

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0042-2027

METOCLOPRAMIDE

Manufacturer / Recalling Firm: American Health Packaging

Reason for Recall: Presence of Foreign Tablets/Capsules

FDA Report: Oct 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose: 60687-620-11

Lots / Batch Codes & Expiration Dates

Lot 1028135, 1029555; Exp. Date 07/31/2027

Distribution Scope

US Nationwide

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0038-2027

METOCLOPRAMIDE

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc

Reason for Recall: Presence of Foreign Tablets/Capsules

FDA Report: Oct 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05

Lots / Batch Codes & Expiration Dates

Lot, expiry: [100 Tablets] Lots 8634085, 8635085, 8636085, exp 07/2027; [500 Tablets] Lot 8633085, exp 07/2027

Distribution Scope

US Nationwide.

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0041-2027

Sermorelin

Manufacturer / Recalling Firm: Houston Rx LLC

Reason for Recall: Lack of process control

FDA Report: Oct 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.

Lots / Batch Codes & Expiration Dates

Lot# SER-081726-1-10, Beyond Use Date: 10/01/2026.

Distribution Scope

Nationwide in the USA.

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0037-2027

Apothecary NAD+ Injection 200 mg/mL

Manufacturer / Recalling Firm: Apothecary Pharma LLC

Reason for Recall: Lack of Assurance of Sterility

FDA Report: Oct 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06.

Lots / Batch Codes & Expiration Dates

Lot #: AP-202647, BUD 13-Oct-2026

Distribution Scope

Nationwide within the United States

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0008-2027

LEADER EYE DROPS REDNESS RELIEF

Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc.

Reason for Recall: Lack of Assurance of Sterility

FDA Report: Oct 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves Dryness, Burning and Irritations), 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; b) Discount drug mart, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, UPC: 0 93351 03411 4; c) EQUALINE, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 46151 2; d) Colirio Ojo de Aguila, Distributed by Grandall Distributing Co., Inc., Glendale, CA 91204, UPC: 3 48201 01615 5; e) Clear Eyes Redness Relief, ¿ 2025 Dist. by Medtech Products Inc., Tarrytown, NY 10591, UPC 6 78112 25415 6; f) Equate", DISTRIBUTED BY WALMART INC., Bentonville, AR 72716, NDC 79903-012-01; g) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Xpect Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC: 130209.

Lots / Batch Codes & Expiration Dates

Lot: a) RL25D01, Exp.: 04/30/2027; RL25G01, Exp.: 07/31/2027; RL25K05, Exp.: 09/30/2027; RL25N03, Exp.: 11/30/2027; b) RL25D01, Exp.: 04/30/2027; RL25G01, Exp.: 07/31/2027; c) RL25D01, Exp.: 04/30/2027; d) RL25E01, Exp.: 05/31/2027; RL25K05, Exp.: 09/30/2027; e) RL25G02, Exp.: 07/31/2027; RL25G03, Exp.: 07/31/2027; RL25G04, Exp.: 07/31/2027; RL25H0...

Distribution Scope

US Nationwide

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0020-2027

SERMORELIN ACETATE 1 MG/ML INJECTABLE

Manufacturer / Recalling Firm: Carolina Infusion, LLC

Reason for Recall: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

FDA Report: Oct 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland

Lots / Batch Codes & Expiration Dates

Lot: 07292026@12, BUD 09/12/2026; 07302026@7, BUD 09/13/2026.

Distribution Scope

Nationwide within the U.S

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0018-2027

SEMAGLUTIDE 3 MG/ML INJECTABLE

Manufacturer / Recalling Firm: Carolina Infusion, LLC

Reason for Recall: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

FDA Report: Oct 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Lots / Batch Codes & Expiration Dates

Lot: 08262026@6, BUD:10/10/2026.

Distribution Scope

Nationwide within the U.S

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0019-2027

SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE

Manufacturer / Recalling Firm: Carolina Infusion, LLC

Reason for Recall: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

FDA Report: Oct 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Lots / Batch Codes & Expiration Dates

Lot: 07282026@3, BUD: 9/11/2026; 08252026@9, BUD: 10/9/2026; 08042026@12, BUD: 9/18/2026; 08072026@15, BUD: 9/21/2026.

Distribution Scope

Nationwide within the U.S

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0003-2027

GOODSENSE EYE DROPS IRRITATION RELIEF

Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc.

Reason for Recall: Lack of Assurance of Sterility

FDA Report: Oct 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; b) Good Sense Sterile Eye Drops, Distributed By: Geiss, Destin & Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-121-01; c) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7; d) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; e) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6.

Lots / Batch Codes & Expiration Dates

Lot: a) AC25C01, Exp.: 3/31/2027; b) AC25B01, Exp.: 2/28/2027; AC25C01, Exp.: 3/31/2027; c) AC25C01, Exp.: 3/31/2027; d) AC25C01, Exp.: 3/31/2027; e) AC25C01, Exp.: 3/31/2027.

Distribution Scope

US Nationwide

Open Dedicated Detail Page Official OpenFDA Source

Class III (Low Risk)

Drug recall Recall #: D-0033-2027

TRETINOIN

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC

Reason for Recall: Failed Impurities/Degradation Specifications

FDA Report: Oct 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.

Lots / Batch Codes & Expiration Dates

Lot # AD96184, Exp Date: 12/31/2026.

Distribution Scope

US Nationwide.

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0026-2027

SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE

Manufacturer / Recalling Firm: Carolina Infusion, LLC

Reason for Recall: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

FDA Report: Oct 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

View Full Report

Affected Product Description

SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Lots / Batch Codes & Expiration Dates

Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. .

Distribution Scope

Nationwide within the U.S

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0002-2027

LEADER ARTIFICIAL TEARS 15 ML

Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc.

Reason for Recall: Lack of Assurance of Sterility

FDA Report: Oct 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

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Affected Product Description

Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47008 3; b) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428, NDC 24385-006-05; d) Good Sense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-110-01; e) Medic'c Choice, Sterile 0.5 fl. oz. (15 mL), Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-008-01; f) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; g) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; I) Walgreens, DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015, UPC 3 11917 06503 8; J) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7.

Lots / Batch Codes & Expiration Dates

Lot: a) AT25B01, Exp.: 2/28/2027; b) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; c) AT25D01, Exp.: 04/30/27; AT25K02, Exp.: 9/30/2027; d) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/20...

Distribution Scope

US Nationwide

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0017-2027

TIRZEPATIDE 26 MG/ML INJECTABLE

Manufacturer / Recalling Firm: Carolina Infusion, LLC

Reason for Recall: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

FDA Report: Oct 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA

View Full Report

Affected Product Description

TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;

Lots / Batch Codes & Expiration Dates

Lots: 09012026@3, BUD: 10/16/2026; 08032026@16, BUD: 9/17/2026; 08052026@8, BUD: 9/19/2026; 08072026@13, BUD: 9/21/2026.

Distribution Scope

Nationwide within the U.S

Open Dedicated Detail Page Official OpenFDA Source

Class II (Moderate Risk)

Drug recall Recall #: D-0012-2027

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.

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