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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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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

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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

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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

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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

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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

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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

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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

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Drug Recall Ongoing Historical recordClass I

Samurai-X Honey 6800, UPC 2 56891 27553 3.

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

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Drug Recall Ongoing Historical recordClass I

Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.

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

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Drug Recall Ongoing Historical recordClass I

Weiner Boner Honey, 12g packet, 100% Organic Formula.

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

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Drug Recall Ongoing Historical recordClass I

Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455

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

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Drug Recall Completed Historical recordClass II

S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.

by Specialty Process Labs LLC

Reason: Failed Stability Specifications
Recall initiated: March 1, 2024
Reported by FDA: April 24, 2024
Distribution: U.S. Nationwide.

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Drug Recall Completed Historical recordClass II

Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01

by Eli Lilly & Company

Reason: CGMP Deviations
Recall initiated: March 12, 2024
Reported by FDA: April 24, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass III

Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10

by Novitium Pharma LLC

Reason: Failed Impurities/Degradation Specifications
Recall initiated: March 25, 2024
Reported by FDA: April 24, 2024
Distribution: U.S. Nationwide

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Drug Recall Terminated Historical recordClass I

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

by Amneal Pharmaceuticals of New York, LLC

Reason: Superpotent Drug: Due to overfilling of drug powder
Recall initiated: March 21, 2024
Reported by FDA: April 24, 2024
Distribution: Nationwide in the USA.

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Drug Recall Completed Historical recordClass III

NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03

by Esperion

Reason: Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Recall initiated: March 27, 2024
Reported by FDA: April 24, 2024
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03

by Specialty Process Labs LLC

Reason: Failed Stability Specifications
Recall initiated: March 1, 2024
Reported by FDA: April 24, 2024
Distribution: U.S. Nationwide.

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Data last updated: November 1, 2026 ET

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.