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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 2,541–2,560 of 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bottle, packaged in a) equate, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716, 2-0.5 FL OZ (15 mL) Bottles, 1 FL OZ (30 mL) TOTAL, UPC 6 81131 36701 1, NDC 49035-280-02; b) DG health, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; c) sunmark, Distributed By McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 62144 3, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; e) HealthMart, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 52569 13715 4; f) exchange select Artificial Tears, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; g) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, UPC 7 13733 29692 2, NDC 41250-718-01; h) H.E.B, MADE WITH PRIDE AND CARE FOR H.E.B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; i) GeriCare, Distributed by: Gericare Pharmaceuticals Corp., 1650 63rd St., Brooklyn, NY 11204, UPC 3 57896 18405 6, NDC 57896-181-05

by K.C. Pharmaceuticals, Inc

Reason
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Recall initiated
June 13, 2023
Reported by FDA
July 19, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; b) Publix, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 01076 5; c) sterile eye drops, Original Formula, sunmark, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 16733 0, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; e) Eye Drops, Original Formula, GoodSense, Distributed By: Geiss, Destin & Dunn, Inc., Peachtree City, GA 30269, UPC 1 80410 00015 6, NDC 50804-141-01; f) sterile eye drops, Circle K, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404 Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; g) Sterile Eye Drops, Regular Formula, Lil Drug Store, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404; UPC 3 66715 68324 3; h) Tetrahydrozoline Ophthalmic Solution, Rugby, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, UPC 3 05361 21794 5, NDC 0536-1217-94, i) Leader, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, UPC 0 96295 13645 6, NDC 70000-0454-1; j) REDNESS RELIEF EYE DROPS, CAREone, Distributed by: FOODHOLD USA, LLC, LANDOVER, MD 20785; UPC 0 41520 86531 1, NDC 41520-431-05; k) Eye Drops, Original Formula, Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, UPC 0 87701 14975 7, NDC 24385-075-05; l) Eye Drops, ORIGINAL FORMULA, Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, UPC 3 11917 20076 7; m) CVS Health, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 36131 3; n) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; o) redness relief, Original Redness Reliever Eye Drops, meijer, DIST. BY MEIJER DISTRIBUTION INC., GRAND RAPIDS, MI 49544, UPC 0 41250 82916 4, NDC 41250-814-01; p) Eye Drops, ORIGINAL, Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47011 3

by K.C. Pharmaceuticals, Inc

Reason
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Recall initiated
June 13, 2023
Reported by FDA
July 19, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10,

by Vivus, Inc.

Reason
Failed Stability Specifications
Recall initiated
June 23, 2023
Reported by FDA
July 19, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-08

by Strides Pharma Inc.

Reason
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Recall initiated
June 26, 2023
Reported by FDA
July 12, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.

by Preferred Pharmaceuticals, Inc.

Reason
Failed Stability Specifications
Recall initiated
June 26, 2023
Reported by FDA
July 12, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.

by Amerisource Health Services LLC

Reason
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Recall initiated
June 23, 2023
Reported by FDA
July 12, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Subpotent drug
Recall initiated
May 30, 2023
Reported by FDA
July 5, 2023
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03

by Ferring Pharmaceuticals Inc

Reason
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Recall initiated
June 12, 2023
Reported by FDA
July 5, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61

by The Harvard Drug Group

Reason
Packaging defect: blister packaging inadequately sealed.
Recall initiated
June 16, 2023
Reported by FDA
July 5, 2023
Distribution
Nationwide in the U.S.

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.

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