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 II Ongoing
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 3827…
Reason: CGMP Deviations:Noted during FDA inspection
Lots, distribution and details
- Product
- SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.
- Lots / codes
- Lot: SDC2505001, Date of Expiry: April 30, 2030.
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 25 KG, 25 X 1.00 KG bags
- Recall started
- August 3, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0763-2026
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Class II Ongoing
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 3827…
Reason: CGMP Deviations:Noted during FDA inspection
Lots, distribution and details
- Product
- SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05
- Lots / codes
- Batch SDC2505001, Date of Expiry: April 30, 2030.
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 25KG, 250-1gm bags
- Recall started
- August 3, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0759-2026
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Class I Ongoing
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Reason: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Lots, distribution and details
- Lots / codes
- All codes; Exp 12/31/2029
- Distribution
- Product was distributed to 4 customers in the US.
- Quantity
- 4
- Recall started
- December 15, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0397-2026
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Class I Ongoing
Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0
Reason: Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Lots, distribution and details
- Lots / codes
- ALL LOTS, exp 12/31/2027
- Distribution
- U.S. Nationwide
- Quantity
- 125 boxes
- Recall started
- October 8, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0396-2026
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Class I Ongoing
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Lots, distribution and details
- Lots / codes
- All lots Lot #: KT-1ST-43-0110/2025, Exp. 03/15/2026
- Distribution
- Nationwide
- Quantity
- 300 boxes
- Recall started
- April 14, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0467-2025
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Class I Ongoing
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Lots, distribution and details
- Lots / codes
- All lots Lot #: KT-1ST-43-01-10/2025, Exp. 01/10/2027
- Distribution
- Nationwide
- Quantity
- 500 boxes
- Recall started
- April 14, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0466-2025
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Class I Ongoing
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Lots, distribution and details
- Lots / codes
- All lots Lot #: KT-1ST-43-01-07/2024, Exp. 10/15/2026
- Distribution
- Nationwide
- Quantity
- 300 boxes
- Recall started
- April 14, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0465-2025
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Class I Ongoing
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Lots, distribution and details
- Lots / codes
- All lots Lot #: KT-1ST-43-01-04/2026, Exp. 04/25/2026
- Distribution
- Nationwide
- Quantity
- 500 boxes
- Recall started
- April 14, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0464-2025
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Class I Ongoing
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Lots, distribution and details
- Lots / codes
- All Lots Lot #: KT-1ST-43-01-10-2025, Exp. 01/10/2027
- Distribution
- Nationwide
- Quantity
- 3000 boxes
- Recall started
- April 14, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0463-2025
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Class I Ongoing
ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement….rgy and Endurance, UPC X004BB9Z8N
Reason: Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Lots, distribution and details
- Product
- ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement….rgy and Endurance, UPC X004BB9Z8N
- Lots / codes
- Lot: 250214PRO, Expiration Date: 02/14/2027.
- Distribution
- Nationwide Via Amazon Platform
- Quantity
- 600, 20-count cartons
- Recall started
- May 6, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0453-2025
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Class I Ongoing
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide in the U.S.A
- Quantity
- a) 300 individually wrapped capsules b) 20 bottles
- Recall started
- February 20, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0281-2025
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Class I Ongoing
ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Lots, distribution and details
- Lots / codes
- Lot #: YZM240406, Exp: 04/05/2027
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- November 4, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0086-2025
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Class I Ongoing
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Lots, distribution and details
- Lots / codes
- Lot #: YZM240406, Exp: 04/05/2027
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- November 4, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0085-2025
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Class I Ongoing
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Lots, distribution and details
- Lots / codes
- Lot #: 230811, Exp: 08/11/2025
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- November 4, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0084-2025
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Class I Ongoing
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Lots, distribution and details
- Lots / codes
- Lot #: 230811, Exp: 08/11/2025
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- November 4, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0083-2025
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Class I Ongoing
Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
Reason: Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)
- Quantity
- 615
- Recall started
- July 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0004-2025
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Class I Ongoing
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Reason: Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)
- Quantity
- 729
- Recall started
- July 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0003-2025
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Class I Ongoing
To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
Reason: Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Lots, distribution and details
- Product
- To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
- Lots / codes
- Lot HGW221116 (Batch 022123-1), Exp 5/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 2500 boxes
- Recall started
- February 1, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0586-2024
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Class I Ongoing
RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
Reason: Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Lots, distribution and details
- Lots / codes
- Lot HGW221116 (Batch 020123-1), Exp 5/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 2500 boxes
- Recall started
- February 1, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0585-2024
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Class I Terminated
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
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.
Lots, distribution and details
- Lots / codes
- All lots within expiry
- Distribution
- USA Nationwide. The product was sold via Amazon Market Place.
- Quantity
- 400 capsules
- Recall started
- February 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0470-2024
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Class I Ongoing
HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, 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
- 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-0458-2024
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Class I Ongoing
ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
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
- 4,351 pieces
- Recall started
- March 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0457-2024
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Class I Ongoing
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.
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
- 10 boxes
- Recall started
- March 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0456-2024
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Class I Ongoing
SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762
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
- 7 pieces
- Recall started
- March 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0455-2024
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Class I Ongoing
libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Lots, distribution and details
- Product
- libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
- Lots / codes
- All lots
- Distribution
- Nationwide in the USA
- Quantity
- 7 boxes
- Recall started
- March 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0454-2024
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.