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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 11,061–11,080 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729

by Allegiant Health

Reason
cGMP deviations - presence of rubber particles found loose in the bulk product.
Recall initiated
February 16, 2017
Reported by FDA
March 8, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20

by United Exchange Corporation

Reason
Lack of assurance of sterility
Recall initiated
September 2, 2016
Reported by FDA
March 8, 2017
Distribution
Nationwide, Puerto Rico and Guyana

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Drug Recall Terminated Historical recordClass II

Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., 17211 Valley View Ave., Cerritos, CA 90703, Made in Korea, UPC Code: 780707005828

by United Exchange Corporation

Reason
Lack of assurance of sterility
Recall initiated
September 2, 2016
Reported by FDA
March 8, 2017
Distribution
Nationwide, Puerto Rico and Guyana

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Drug Recall Terminated Historical recordClass II

Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97

by United Exchange Corporation

Reason
Lack of assurance of sterility
Recall initiated
September 2, 2016
Reported by FDA
March 8, 2017
Distribution
Nationwide, Puerto Rico and Guyana

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Drug Recall Terminated Historical recordClass I

EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20

by United Exchange Corporation

Reason
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Recall initiated
September 2, 2016
Reported by FDA
March 8, 2017
Distribution
Nationwide, Puerto Rico and Guyana

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Drug Recall Terminated Historical recordClass II

Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., North Chicago, IL 60064 --- NDC 0074-3012-07

by AbbVie Inc.

Reason
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
Recall initiated
January 13, 2017
Reported by FDA
March 8, 2017
Distribution
TN and IL

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Drug Recall Terminated Historical recordClass I

Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA

by Jeffreys Drug Store

Reason
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Recall initiated
November 23, 2016
Reported by FDA
March 8, 2017
Distribution
PA

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Drug Recall Terminated Historical recordClass II

glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10

by Mylan Pharmaceuticals Inc.

Reason
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Recall initiated
January 19, 2017
Reported by FDA
March 8, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25

by Amerisource Health Services

Reason
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Recall initiated
February 8, 2017
Reported by FDA
March 8, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, Rx only, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013, Reorder #6306, UPC 6 18029 83041 8.

by Sage Products Inc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.
Recall initiated
February 2, 2017
Reported by FDA
March 1, 2017
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottles, Rx only, Moore's Pharmacy Compounding, Corpus Christi, TX

by MOORE'S COMPOUNDING PHARMACY

Reason
Superpotent Drug and Subpotent Drug; potency failures obtained
Recall initiated
September 12, 2016
Reported by FDA
March 1, 2017
Distribution
TX

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Drug Recall Terminated Historical recordClass II

MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. (35 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-203-35

by Cherry Hill Sales Co.

Reason
CGMP Deviations
Recall initiated
January 27, 2017
Reported by FDA
March 1, 2017
Distribution
Michigan, Illinois, New York, Florida, Pennsylvania .

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Drug Recall Terminated Historical recordClass II

MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-208-28

by Cherry Hill Sales Co.

Reason
CGMP Deviations
Recall initiated
January 27, 2017
Reported by FDA
March 1, 2017
Distribution
Michigan, Illinois, New York, Florida, Pennsylvania .

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Drug Recall Terminated Historical recordClass II

MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMIN E, Camphor-1% Menthol-1%, 1oz.(28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-201-28

by Cherry Hill Sales Co.

Reason
CGMP Deviations
Recall initiated
January 27, 2017
Reported by FDA
March 1, 2017
Distribution
Michigan, Illinois, New York, Florida, Pennsylvania .

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Drug Recall Terminated Historical recordClass II

MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-210-28

by Cherry Hill Sales Co.

Reason
CGMP Deviations
Recall initiated
January 27, 2017
Reported by FDA
March 1, 2017
Distribution
Michigan, Illinois, New York, Florida, Pennsylvania .

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Drug Recall Terminated Historical recordClass II

MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxide-12.50%,1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-205-28

by Cherry Hill Sales Co.

Reason
CGMP Deviations
Recall initiated
January 27, 2017
Reported by FDA
March 1, 2017
Distribution
Michigan, Illinois, New York, Florida, Pennsylvania .

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Drug Recall Terminated Historical recordClass II

Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02

by RemedyRePack Inc.

Reason
Failed Dissolution Specifications
Recall initiated
February 7, 2017
Reported by FDA
March 1, 2017
Distribution
Product was distributed to a sold customer in FL.

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Drug Recall Terminated Historical recordClass II

Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540.

by Sandoz Inc

Reason
Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
Recall initiated
February 2, 2017
Reported by FDA
March 1, 2017
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24

by Hospira Inc., A Pfizer Company

Reason
Lack of Sterility Assurance: customer report of leaking bag
Recall initiated
February 10, 2017
Reported by FDA
March 1, 2017
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0

by Apotex Inc.

Reason
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Recall initiated
February 3, 2017
Reported by FDA
March 1, 2017
Distribution
Distributed Nationwide

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.