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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 1,681–1,700 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53

by Cipla USA, Inc.

Reason
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Recall initiated
March 26, 2024
Reported by FDA
May 1, 2024
Distribution
USA nationwide.

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Drug Recall Terminated Historical recordClass I

ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.

by FA Online Inc

Reason
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Recall initiated
February 12, 2024
Reported by FDA
May 1, 2024
Distribution
USA Nationwide. The product was sold via Amazon Market Place.

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Drug Recall Ongoing Historical recordClass III

Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13

by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Reason
Cross Contamination with Other Products
Recall initiated
April 9, 2024
Reported by FDA
May 1, 2024
Distribution
USA nationwide.

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Drug Recall Ongoing Historical recordClass III

Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13

by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Reason
Cross Contamination with Other Products
Recall initiated
April 9, 2024
Reported by FDA
May 1, 2024
Distribution
USA nationwide.

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Drug Recall Ongoing Historical recordClass III

Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.

by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Reason
Cross Contamination with Other Products
Recall initiated
April 9, 2024
Reported by FDA
May 1, 2024
Distribution
USA nationwide.

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Drug Recall Ongoing Historical recordClass III

Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13

by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Reason
Cross Contamination with Other Products
Recall initiated
April 9, 2024
Reported by FDA
May 1, 2024
Distribution
USA nationwide.

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Drug Recall Ongoing Historical recordClass II

FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.

by Nomax Inc

Reason
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Recall initiated
April 19, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.

by Nomax Inc

Reason
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Recall initiated
April 19, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40.

by Nomax Inc

Reason
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Recall initiated
April 19, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.

by Nomax Inc

Reason
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Recall initiated
April 19, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37

by HONEYWELL INC

Reason
CGMP Deviations
Recall initiated
March 29, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide USA, Canada

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Drug Recall Ongoing Historical recordClass I

Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5

by Aruba Aloe Balm N.V.

Reason
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Recall initiated
March 23, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean.

by Aruba Aloe Balm N.V.

Reason
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Recall initiated
March 23, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A

by Pyramids Wholesale Inc.

Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Recall initiated
March 19, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L

by Pyramids Wholesale Inc.

Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Recall initiated
March 19, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.

by Pyramids Wholesale Inc.

Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Recall initiated
March 19, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762

by Pyramids Wholesale Inc.

Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Recall initiated
March 19, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.

by Pyramids Wholesale Inc.

Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Recall initiated
March 19, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.

by Pyramids Wholesale Inc.

Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Recall initiated
March 19, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557

by Pyramids Wholesale Inc.

Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Recall initiated
March 19, 2024
Reported by FDA
May 1, 2024
Distribution
Nationwide in the USA

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.