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)
63
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 II (Moderate Risk)
Drug recall
Recall #: D-0009-2027
LEADER ULTRA LUBRICATING EYE DROPS
Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 1429905619 0; c) Good Sense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, NDC 50804-160-01; d) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20167 2.
Lots / Batch Codes & Expiration Dates
Lot: a) SU25B01, Exp.: 02/28/2027; b) SU25N01, Exp.: 11/30/2027; c) SU25B01, Exp.: 02/28/2027; SU25N01, Exp.: 11/30/2027; SU25N02, Exp.: 11/30/2027; d) SU25B01, Exp.: 02/28/2027.
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0030-2027
TIRZEPATIDE/CYANOCOBALAMIN 85/2 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.
Affected Product Description
TIRZEPATIDE/CYANOCOBALAMIN 85/2 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:07212026@9, BUD: 9/4/2026; 07252026@2, BUD: 9/8/2026; 08122026@14, BUD: 9/26/2026; 08272026@8, BUD: 10/11/2026; 08312026@18, BUD: 10/15/2026.
Distribution Scope
Nationwide within the U.S
Class III (Low Risk)
Drug recall
Recall #: D-0034-2027
TRETINOIN
Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Impurities/Degradation Specifications
Affected Product Description
Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02.
Lots / Batch Codes & Expiration Dates
Lot # AD96183, Exp Date: 12/31/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0031-2027
Tri-MIX
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.
Affected Product Description
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, 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: 07212026@1, BUD: 9/10/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0013-2027
Lidocaine Ointment USP
Manufacturer / Recalling Firm: Preferred Pharmaceuticals, Inc.
Reason for Recall: Failed Content Uniformity Specifications
Affected Product Description
Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 68788-7865-05
Lots / Batch Codes & Expiration Dates
Lot #: F1925G, Expiry: 4/30/2027; Lot #: E0925T, Expiry: 4/30/2027; Lot # D3025M, Expiry: 4/30/2027; Lot #: D0825D, Expiry: 4/30/2027.
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0036-2027
Tirzepatide Injection
Manufacturer / Recalling Firm: Apothecary Pharma LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.
Lots / Batch Codes & Expiration Dates
Lot #: AP-202622, BUD 07-Oct-2026; AP-202623, BUD 08-Oct-2026; AP-202624, BUD 19-Oct-2026; AP-202625, BUD 10/20/2026; AP-202627, BUD 10/26/2026; AP-202628, BUD 10/27/2026; AP-202629, BUD 10/28/2026; AP-202630, BUD 10/31/2026; AP-202631, BUD 11/01/2026; AP-202632, BUD 11/03/2026; AP-202633, BUD 11/07/2026; AP-202634, BUD 11/08/2026; AP-202635, BUD 1...
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0024-2027
Tri-MIX
Manufacturer / Recalling Firm: Carolina Infusion, LLC
Reason for Recall: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Affected Product Description
Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, 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:08042026@8, BUD: 9/18/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0007-2027
GOODSENSE EYE DROPS ORIGINAL FORMULA
Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47011 3; b) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01157 3; c) Good Sense Sterile Eye Drops, Distributed By: Geiss, Destin & Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-141-01; d) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; e) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71302 5; f) Circle K, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed: by Circle K Stores Inc., UPC: 1 94283 65135 8; g) Lil' DrugStore, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, UPC: 3 66715 68324 3; h) QC, Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-340-15; i) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; j) Equate", DISTRIBUTED BY WALMART INC., Bentonville, AR 72716, NDC 79903-158-05; k) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20073 6; l) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38597 0.
Lots / Batch Codes & Expiration Dates
Lot: a) RG24N02, Exp.: 11/30/2026; b) RG25K04, Exp.: 09/30/2027; c) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K02, Exp.: 09/30/2027; RG25K03, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; d) RG24N02, Exp.: 11/30/2026; e) RG25K04, Exp.: 09/30/2027; f) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG2...
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0016-2027
IMAAVY
Manufacturer / Recalling Firm: J&J INNOVATIVE MEDICINE
Reason for Recall: Presence of particulate matter.
Affected Product Description
IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01
Lots / Batch Codes & Expiration Dates
Lot JNYJ1208; Exp. 10/30/2027
Distribution Scope
OH
Class II (Moderate Risk)
Drug recall
Recall #: D-0032-2027
Tri-MIX
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.
Affected Product Description
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, 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@2, BUD: 9/11/2026; 08032026@11, BUD: 9/17/2026; 08042026@3, BUD: 9/18/2026. .
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0014-2027
FOSFOMYCIN TROMETHAMINE
Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Failed Impurities/Degradation Specifications
Affected Product Description
Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.
Lots / Batch Codes & Expiration Dates
Lot#: 5KA0405, Exp 12/31/2026.
Distribution Scope
USA Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0004-2027
LEADER ADVANCED RELIEF EYE DROPS
Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0456-1; b) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25392 6; c) GoodSense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; d) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43745 0; e) Medic'c Choice, Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-025-01; f) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, NDC 70677-1158-1; g) Colirio Manzanill A+, Distributed by: PRO-MEX, P.O Box 63-0716, Miami , FL 33163, UPC: 1 84125 00018 0; h) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 06776 9; I) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; J) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3.
Lots / Batch Codes & Expiration Dates
Lot: a) AR25A02, Exp.: 1/1/2027; b) AR25A02, Exp.: 1/1/2027; c) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; d) AR25A02, Exp.: 1/1/2027; e) AR25A02, Exp.: 1/1/2027; f) AR25A02, Exp.: 1/1/2027; g) AR25F01, Exp.: 6/30/2027; AR25N01, Exp.: 11/30/2027; h) AR25A02, Exp.: 1/1/2027; I) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; J) AR25A01,...
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0025-2027
Tri-MIX
Manufacturer / Recalling Firm: Carolina Infusion, LLC
Reason for Recall: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Affected Product Description
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, 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:08062026@10, BUD: 9/20/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0023-2027
Tri-MIX
Manufacturer / Recalling Firm: Carolina Infusion, LLC
Reason for Recall: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Affected Product Description
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, 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@7, BUD: 09/7/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0022-2027
Tri-MIX
Manufacturer / Recalling Firm: Carolina Infusion, LLC
Reason for Recall: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Affected Product Description
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, 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: 08072026@2, BUD:9/21/2026; 08032026@10, BUD:09/17/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0027-2027
TIRZEPATIDE/CYANOCOBALAMIN 26/2 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.
Affected Product Description
TIRZEPATIDE/CYANOCOBALAMIN 26/2 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:07212026@18, BUD: 9/4/2026; 07222026@14, BUD: 9/5/2026; 07292026@8, BUD: 9/12/2026; 08052026@14, BUD: 9/19/2026; 08142026@1, BUD: 9/28/2026; 08192026@10, BUD: 10/3/2026; 08242026@25, BUD: 10/8/2026; 08282026@2, BUD: 10/12/2026; 08292026@1, BUD:10/13/2026;
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0021-2027
QUAD-MIX
Manufacturer / Recalling Firm: Carolina Infusion, LLC
Reason for Recall: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Affected Product Description
QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) 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: 08032026@24, BUD: 09/17/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0006-2027
LEADER DRY EYE RELIEF EYE DROPS
Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Crocodile Tears, Palm Beach Gardens, FL 33410, UPC: 8 67166 00000 4; c) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01156 6; d) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 05620 6; e) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., 1295 Towbin Ave., Lakewood, NJ 08701, NDC 57896-181-05; f) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71303 2; h) Foster & Thrive, Distributed by: McKesson Corp. Via Strategic Sourcing Servies LLC., Memphis, TN 38141, NDC 70677-1157-1; I) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3.
Lots / Batch Codes & Expiration Dates
Lot: a) LT25B01, Exp.: 02/28/2027; b) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; c) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; d) LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027; e) LT25B01, Exp.: 02/28/2027; LT25D01, Exp.: 04/30/2027; LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; LT25M01, Exp.: 10/31/2027; LT25M0...
Distribution Scope
US Nationwide
Class I (High Risk)
Drug recall
Recall #: N/A
Tri-Immune Boost
Manufacturer / Recalling Firm: Centric Compounding LLC
Reason for Recall: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Affected Product Description
Tri-Immune Boost (Glutathione: 200 mg, Ascorbic Acid: 200 mg, Zinc: 2.5 mg), 30 mL vial, Rx only, Centric Compounding, 7447 Harwin Dr. Suite 111, Houston, TX 77036
Lots / Batch Codes & Expiration Dates
Lot #: 071626:B, Beyond Use Date: 8/30/26
Distribution Scope
USA Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0878-2026
Benzoyl Peroxide Wash
Manufacturer / Recalling Firm: SV Labs Toronto Corporation
Reason for Recall: Microbial contamination of topical product.
Affected Product Description
Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63
Lots / Batch Codes & Expiration Dates
Lot #: 0525-02-345, Exp. Date 02/2027
Distribution Scope
IL only