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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
2 weeks ago
Total FDA Recalls
999
Active / Ongoing
962
Critical (Class I)
45
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
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinib...
Blaine Labs Inc Jul 08, 2026
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Ste...
CareFusion 213, LLC Jul 01, 2026
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides.
CareFusion 213, LLC Jul 01, 2026
Showing 161–180 of 999 factual FDA recall reports
Class III (Low Risk)
Drug recall Recall #: D-0534-2026

PRIMIDONE

Manufacturer / Recalling Firm: Golden State Medical Supply Inc.
Reason for Recall: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05
Lots / Batch Codes & Expiration Dates
Lot#: GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028
Distribution Scope
USA Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0537-2026

PRIMIDONE

Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Lots / Batch Codes & Expiration Dates
Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0544-2026

ERYTHROMYCIN

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).
Lots / Batch Codes & Expiration Dates
Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0541-2026

LIRAGLUTIDE

Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: Presence of particulate matter: a white thread-like structure in the cartridge
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.
Lots / Batch Codes & Expiration Dates
Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB00098, WB00092, WB00093, Expires: Jul. 2027; WB00104, WB00106, WB00105, Expires: Oct. 2027.
Distribution Scope
Nationwide within U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0545-2026

ERYTHROMYCIN

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).
Lots / Batch Codes & Expiration Dates
Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0548-2026

fentaNYL Citrate

Manufacturer / Recalling Firm: IntegraDose Compounding Services LLC
Reason for Recall: Subpotent Drug
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.
Lots / Batch Codes & Expiration Dates
Lot#: 20260310FEN-1, Exp. Date: 09/06/2026
Distribution Scope
Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0538-2026

ATOMOXETINE

Manufacturer / Recalling Firm: Safecor Health, LLC
Reason for Recall: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01
Lots / Batch Codes & Expiration Dates
Lot #: 25530722
Distribution Scope
TX only
Class II (Moderate Risk)
Drug recall Recall #: D-0547-2026

METOPROLOL SUCCINATE

Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Dissolution Specifications
FDA Report: May 20, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.
Lots / Batch Codes & Expiration Dates
Lot # 25140859; Exp. Date: Jan 2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0527-2026

BUPRENORPHINE HYDROCHLORIDE

Manufacturer / Recalling Firm: ENDO USA, Inc.
Reason for Recall: Crystallization; identified as Buprenorphine free base
FDA Report: May 20, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Lots / Batch Codes & Expiration Dates
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0525-2026

OASIS TEARS PF

Manufacturer / Recalling Firm: Oasis Medical, Inc.
Reason for Recall: Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
FDA Report: May 20, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.
Lots / Batch Codes & Expiration Dates
Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0515-2026

DULOXETINE

Manufacturer / Recalling Firm: Ajanta Pharma Ltd.
Reason for Recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
Lots / Batch Codes & Expiration Dates
Lot#: PA07434, Exp. May 2026.
Distribution Scope
Nationwide within U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0512-2026

DELFLEX

Manufacturer / Recalling Firm: Fresenius Medical Care Holdings, Inc.
Reason for Recall: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Lots / Batch Codes & Expiration Dates
Lot #: 25CU02007, 25CU02008, 25CU02009
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0519-2026

OCTREOTIDE ACETATE

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.
Lots / Batch Codes & Expiration Dates
Lot: 45011002, Exp. 03/31/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0513-2026

DELFLEX

Manufacturer / Recalling Firm: Fresenius Medical Care Holdings, Inc.
Reason for Recall: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Lots / Batch Codes & Expiration Dates
Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0540-2026

LACTATED RINGERS

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Presence of Particulate Matter.
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
Lots / Batch Codes & Expiration Dates
Lot #:J4P756, J4S843, Exp 5/31/2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0522-2026

DULOXETINE

Manufacturer / Recalling Firm: Breckenridge Pharmaceutical, Inc.
Reason for Recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Lots / Batch Codes & Expiration Dates
Lot: 241069C, Exp 05/31/2027
Distribution Scope
Nationwide in the USA
Class III (Low Risk)
Drug recall Recall #: D-0511-2026

BUSPIRONE HYDROCHLORIDE

Manufacturer / Recalling Firm: Unichem Pharmaceuticals USA Inc.
Reason for Recall: Subpotent drug
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
Lots / Batch Codes & Expiration Dates
Lot: ZBUL25001, Exp 12/31/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0516-2026

DULOXETINE

Manufacturer / Recalling Firm: Ajanta Pharma Ltd.
Reason for Recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
Lots / Batch Codes & Expiration Dates
Lot#: PA10734, Exp. Jun 2026.
Distribution Scope
Nationwide within U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0520-2026

ENALAPRIL MALEATE

Manufacturer / Recalling Firm: JB Chemicals and Pharmaceuticals Ltd
Reason for Recall: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
Lots / Batch Codes & Expiration Dates
Lot #: GEH25023, Expires: 6/30/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0523-2026

NAPROXEN

Manufacturer / Recalling Firm: Acella Pharmaceuticals, LLC
Reason for Recall: Chemical contamination; presence of lead and lithium above specification
FDA Report: May 13, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
Lots / Batch Codes & Expiration Dates
Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Distribution Scope
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