FDA Recalls

The latest food, drug and medical device recalls reported by the U.S. Food and Drug Administration, newest first. Data updated Oct 21, 2026.

87,918 recalls · page 4 of 30

Class IIFoodOngoing
Sweet Sensi Elevated Edibles Hybrid Gum Drops - Passion Guava Kush 140mg THC. Product is packaged in sealable & flexible gold, purple and black metallic plastic mylar pouch and is sold in two sizes: 1) Net wt. Approx. 2.1oz (60g) 10 count and 2) Net wt. 6.3oz (180g) 30 count. Batch #1811, Manufactured by Sweet Sensi Austin, TX 78734. UPC 850043378020
SWEET SENSI · Austin, TX
Class IIFoodOngoing
Cranberry Chicken Salad Wedge 4.5 oz package in Wedge plastic and clear container with a plastic film sealing the top.
FRESHPOINT CENTRAL FLORIDA, INC. · Orlando, FL
Class IIDrugOngoing
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.
Class IIDrugOngoing
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
Class IIDrugOngoing
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
Class IIDrugOngoing
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,
Class IIDrugOngoing
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,
Class IIDrugOngoing
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
Class IIDrugOngoing
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.
Class IIDrugOngoing
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.
Class IIDrugOngoing
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
Class IIDrugOngoing
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
Class IIDrugOngoing
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.
Class IIDrugOngoing
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
Class IIDrugOngoing
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.
Apothecary Pharma LLC · Cary, NC
Class IIDrugOngoing
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
Preferred Pharmaceuticals, Inc. · Anaheim, CA
Class IIDrugOngoing
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
Class IIIDrugOngoing
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.
Class IIDrugOngoing
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;
Class IIDrugOngoing
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.
Class IIDrugOngoing
TIRZEPATIDE/CYANOCOBALAMIN 64/2 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
Class IIIDrugOngoing
Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-0.
SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ
Class IIDrugOngoing
Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 89636 9; b) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 73589 8; c) TYSON, MIKE RED EYE DROPS, Distributed by: JBRANDS Distribution, Miami, FL 33009, UPC: 7 84847 57549 4; d) up & up, Distributed by: Target Corporation, Minneapolis, MN 55403, NDC 11673-100-01; e) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 21123 0; f) Walgreens, DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20075 0.
Class IIDrugOngoing
TIRZEPATIDE/CYANOCOBALAMIN 76/2 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
Class IIDrugOngoing
Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
BioSpectra, Inc. · Bangor, PA
Not Yet ClassifiedDrugOngoing
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
Centric Compounding LLC · Tomball, TX
Class IIDrugOngoing
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;
Class IIDrugOngoing
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.
Class IIDrugOngoing
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
Class IIIDrugOngoing
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.
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Source: openFDA enforcement reports. Not for medical decisions; data may be incomplete or unvalidated.

Staphylococcus aureus detected in product.

Reported Oct 14, 2026 · H-0020-2027

The chicken salad sandwich has an improperly declared allergen (egg). While egg is included in the ingredients list on the package label, it is not included in the allergen Contains statement.

Reported Oct 14, 2026 · H-0012-2027

K.C. Pharmaceuticals, Inc. · Pomona, CA

Lack of Assurance of Sterility

Reported Oct 14, 2026 · D-0006-2027

Carolina Infusion, LLC · Ridgeland, SC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Reported Oct 14, 2026 · D-0021-2027

Carolina Infusion, LLC · Ridgeland, SC

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

Reported Oct 14, 2026 · D-0027-2027

Carolina Infusion, LLC · Ridgeland, SC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Reported Oct 14, 2026 · D-0022-2027

Carolina Infusion, LLC · Ridgeland, SC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Reported Oct 14, 2026 · D-0023-2027

Carolina Infusion, LLC · Ridgeland, SC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Reported Oct 14, 2026 · D-0025-2027

K.C. Pharmaceuticals, Inc. · Pomona, CA

Lack of Assurance of Sterility

Reported Oct 14, 2026 · D-0004-2027

Cipla USA, Inc. · Warren, NJ

Failed Impurities/Degradation Specifications

Reported Oct 14, 2026 · D-0014-2027

Carolina Infusion, LLC · Ridgeland, SC

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

Reported Oct 14, 2026 · D-0032-2027

J&J INNOVATIVE MEDICINE · Malvern, PA

Presence of particulate matter.

Reported Oct 14, 2026 · D-0016-2027

K.C. Pharmaceuticals, Inc. · Pomona, CA

Lack of Assurance of Sterility

Reported Oct 14, 2026 · D-0007-2027

Carolina Infusion, LLC · Ridgeland, SC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Reported Oct 14, 2026 · D-0024-2027

Lack of Assurance of Sterility

Reported Oct 14, 2026 · D-0036-2027

Failed Content Uniformity Specifications

Reported Oct 14, 2026 · D-0013-2027

Carolina Infusion, LLC · Ridgeland, SC

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

Reported Oct 14, 2026 · D-0031-2027

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Failed Impurities/Degradation Specifications

Reported Oct 14, 2026 · D-0034-2027

Carolina Infusion, LLC · Ridgeland, SC

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

Reported Oct 14, 2026 · D-0030-2027

K.C. Pharmaceuticals, Inc. · Pomona, CA

Lack of Assurance of Sterility

Reported Oct 14, 2026 · D-0009-2027

Carolina Infusion, LLC · Ridgeland, SC

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

Reported Oct 14, 2026 · D-0028-2027

Failed Impurities/Degradation Specifications

Reported Oct 14, 2026 · D-0035-2027

K.C. Pharmaceuticals, Inc. · Pomona, CA

Lack of Assurance of Sterility

Reported Oct 14, 2026 · D-0005-2027

Carolina Infusion, LLC · Ridgeland, SC

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

Reported Oct 14, 2026 · D-0029-2027

Failed stability specifications

Reported Oct 14, 2026 · D-0012-2027

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

Reported Oct 14, 2026 · N/A

Carolina Infusion, LLC · Ridgeland, SC

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

Reported Oct 14, 2026 · D-0017-2027

K.C. Pharmaceuticals, Inc. · Pomona, CA

Lack of Assurance of Sterility

Reported Oct 14, 2026 · D-0002-2027

Carolina Infusion, LLC · Ridgeland, SC

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

Reported Oct 14, 2026 · D-0026-2027

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Failed Impurities/Degradation Specifications

Reported Oct 14, 2026 · D-0033-2027