Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
52 recalls
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Class I Ongoing
GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide in the USA
- Quantity
- 12 boxes
- Recall started
- March 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0453-2024
-
Class I Ongoing
Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Lots, distribution and details
- Product
- Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA
- Quantity
- 149 boxes
- Recall started
- March 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0452-2024
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Class I Ongoing
Samurai-X Honey 6800, UPC 2 56891 27553 3.
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide in the USA
- Quantity
- N/A
- Recall started
- March 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0451-2024
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Class I Ongoing
Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide in the USA
- Quantity
- N/A
- Recall started
- March 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0450-2024
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Class I Ongoing
Weiner Boner Honey, 12g packet, 100% Organic Formula.
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide in the USA
- Quantity
- 19 boxes
- Recall started
- March 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0449-2024
-
Class I Ongoing
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide in the USA
- Quantity
- 45 boxes
- Recall started
- March 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0448-2024
-
Class I Ongoing
Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ
Reason: Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) – Sildenafil.
Lots, distribution and details
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA. Product was sold via Amazon's Marketplace.
- Quantity
- 500 blister packs
- Recall started
- November 29, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0206-2024
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Class I Ongoing
THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7
Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Lots, distribution and details
- Lots / codes
- Lot# 03032021 Exp: 12/31/2027
- Distribution
- Florida, Bahamas, Turks & Caicos Islands
- Quantity
- 173 capsules
- Recall started
- October 16, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0158-2024
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Class I Ongoing
Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885
Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Lots, distribution and details
- Lots / codes
- All lots, Expires: 01/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 120 bottles
- Recall started
- August 3, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-1150-2023
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Class I Ongoing
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Lots, distribution and details
- Lots / codes
- Lot/Item#: OMS760-B, Exp: 12/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 140 blister packs
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0573-2023
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Class I Ongoing
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Lots, distribution and details
- Lots / codes
- Lot#: RO 927996, Exp: 12/25/2024
- Distribution
- Nationwide in the USA.
- Quantity
- 18 blister cards
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0572-2023
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Class I Ongoing
Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Lots, distribution and details
- Product
- Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.
- Lots / codes
- No lot number, Exp: 06/2026
- Distribution
- Nationwide in the USA.
- Quantity
- 628 blister cards
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0571-2023
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Class I Ongoing
69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
Reason: Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
Lots, distribution and details
- Lots / codes
- all lots within expiry
- Distribution
- USA Nationwide
- Quantity
- N/A
- Recall started
- March 29, 2021 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0688-2021
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Class I Ongoing
Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Reason: Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making them an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
Lots, distribution and details
- Lots / codes
- all lots within expiry
- Distribution
- USA Nationwide
- Quantity
- N/A
- Recall started
- March 29, 2021 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0687-2021
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Class I Ongoing
Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Reason: Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Lots, distribution and details
- Lots / codes
- all lots within expiry
- Distribution
- USA Nationwide
- Quantity
- N/A
- Recall started
- March 29, 2021 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0685-2021
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Class I Ongoing
Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Lots, distribution and details
- Lots / codes
- all lots
- Distribution
- USA Nationwide
- Quantity
- 399 capsules
- Recall started
- April 8, 2021 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0642-2021
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Class I Ongoing
Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Lots, distribution and details
- Lots / codes
- all lots
- Distribution
- USA Nationwide
- Quantity
- 2600 capsules
- Recall started
- April 8, 2021 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0641-2021
-
Class II Ongoing
Imperial Platinum 2000, 1 capsule, UPC 718122040702
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Lots, distribution and details
- Lots / codes
- All
- Distribution
- USA Nationwide
- Quantity
- 200 boxes
- Recall started
- March 31, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0371-2021
-
Class II Ongoing
Burro en Primavera, 2 capsules, UPC 638632431055
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Lots, distribution and details
- Lots / codes
- All
- Distribution
- USA Nationwide
- Quantity
- 500 boxes
- Recall started
- March 31, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0370-2021
-
Class II Ongoing
PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Lots, distribution and details
- Lots / codes
- All
- Distribution
- USA Nationwide
- Quantity
- 500 boxes
- Recall started
- March 31, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0369-2021
-
Class II Ongoing
IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Lots, distribution and details
- Lots / codes
- All
- Distribution
- USA Nationwide
- Quantity
- 200 boxes
- Recall started
- March 31, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0368-2021
-
Class II Ongoing
Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE Distributors Los Angeles CA 90005 UPC 7 15122 05089 4
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Lots, distribution and details
- Lots / codes
- Lot #: GATCO 1805, Exp. Date 12/30/2024 Serial # 715122050894
- Distribution
- Nationwide with the United States
- Quantity
- N/A
- Recall started
- March 30, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0354-2021
-
Class II Ongoing
PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Lots, distribution and details
- Lots / codes
- Lot #: GATCO 01671, Exp Date 12/30/2024 Serial # 728175421856
- Distribution
- Nationwide with the United States
- Quantity
- N/A
- Recall started
- March 30, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0353-2021
-
Class II Ongoing
Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Lots, distribution and details
- Lots / codes
- all lots and expirys
- Distribution
- Nationwide
- Quantity
- N/A
- Recall started
- March 25, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0352-2021
-
Class I Ongoing
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
Reason: Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
Lots, distribution and details
- Product
- APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
- Lots / codes
- All lots
- Distribution
- All product is sold to Ace Distributors, LLC in Orlando, FL, a retail store, who sells directly to owners of gas stations, convenience stores, and smoke shops where it can be further distributed nationwide.
- Quantity
- 100,000 blister cards
- Recall started
- December 23, 2015 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0667-2016
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.