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.
3 Class I (most serious) drug recalls reported in the last 30 days.
3,250 recalls
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Class II Ongoing
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.
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.
Lots, distribution and details
- Lots / codes
- Lot #: 14776, Exp. 05/31/2024.
- Distribution
- Nationwide in the USA
- Quantity
- 15,444 cartons
- Recall started
- April 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0465-2024
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Class II Ongoing
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.
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.
Lots, distribution and details
- Lots / codes
- Lot 14842, Exp. 6/30/2024
- Distribution
- Nationwide in the USA
- Quantity
- 4648 cartons
- Recall started
- April 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0464-2024
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Class II Ongoing
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.
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.
Lots, distribution and details
- Lots / codes
- Lot #: 14708, Exp. 04/30/2024.
- Distribution
- Nationwide in the USA
- Quantity
- 6,960 cartons
- Recall started
- April 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0463-2024
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Class II Ongoing
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.
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.
Lots, distribution and details
- Lots / codes
- Lot #s: a) 14904, Exp. 06/30/2024; Lot 14938, Exp. 07/31/2024; b) Lot 14931, Exp. 06/30/2024
- Distribution
- Nationwide in the USA
- Quantity
- 15,056 cartons
- Recall started
- April 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0462-2024
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Class II Terminated
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
Reason: CGMP Deviations
Lots, distribution and details
- Product
- 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
- Lots / codes
- Manufacturer's Product Number/ Catalog Number: 32-002050-0000; Exp 06/21/2025
- Distribution
- Nationwide USA, Canada
- Quantity
- 10, 605 cartridges
- Recall started
- March 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0461-2024
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Class I Ongoing
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
Reason: Chemical Contamination: Product manufactured with ethanol API that contains methanol
Lots, distribution and details
- Product
- 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
- Lots / codes
- Lot #: 25160, Exp 4/16/2024; 25344, Exp 5/20/2024, 25580, Exp 6/15/2024; 25828, Exp 7/28/2024; 26057, Exp 8/25/2024; 26195, Exp 9/18/2024; 26471, Exp 11/25/2024; 26754, Exp 1/20/2025; 26821, Exp 2/2/2025; 27005, Exp 3/11/2025; 27518, Exp 6/22/2025; 27927, Exp 8/26/2025; 28176, Exp 10/22/2025; 28392, Exp 12/31/2025.
- Distribution
- Nationwide in the USA
- Quantity
- 5299 bottles
- Recall started
- March 23, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0460-2024
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Class I Ongoing
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…
Reason: Chemical Contamination: Product manufactured with ethanol API that contains methanol
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Lot, expiry: (a) 25253, Exp 5/1/2024; 25976, Exp 8/11/2024; 26150, Exp 9/11/2024; 26473, Exp 11/25/2024; 26553, Exp 12/11/2024; 27318, Exp 5/10/2025; 27481, Exp 6/15/2025; 27660, Exp 7/15/2025; 27839, Exp 8/5/2025; 28121, Exp 10/7/2025; 28152, Exp 10/18/2025; 28355, Exp 12/17/2025; 28761, Exp 2/22/2026; 29088, Exp 4/1/2026; 29510, Exp 5/11/2026; 29558, Exp 5/13/2026; 29728, Exp 6/3/2026; 30339, Exp 9/13/2026; 30563, Exp 10/27/2026. (b) 25253, Exp 5/1/2024; 25976, Exp 8/11/2024; 26150, Exp 9/11/2024; 26553, Exp 12/11/2024; 26696, Exp 1/8/2025; 27318, Exp 5/10/2025; 27481, Exp 6/15/2025; 27660, Exp 7/15/2025; 27839, Exp 8/5/2025; 28281, Exp 11/30/2025; 28355, Exp 12/17/2025; 28761, Exp 2/22/2026; 29088, Exp 4/1/2026; 29728, Exp 6/3/2026; 30086, Exp 7/26/2026; 30339, Exp 9/13/2026; 30563, Exp 10/27/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 9,625 bottles
- Recall started
- March 23, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0459-2024
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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
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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
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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
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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
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Class II Completed
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
Reason: Failed Stability Specifications
Lots, distribution and details
- Lots / codes
- Lot #: L13152-1XV, Exp: 11/21/2024; a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: B10383-1XV, Exp: 02/14/2025, a)1 kg, b)0.5 kg, c)100g pack sizes. Lot #: B10453-1X, Exp: 02/15/2025, a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: C10803-1X, Exp: 03/23/2025, a)1.00 kg, c)100g pack sizes. Lot #: E11363-1X, Exp: 05/18/2025, a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: K12753-1X, Exp: 10/12/2025, a)1.00 kg pack sizes. Lot #: L13103-1X, Exp: 11/13/2025, a)1 kg, b)0.5 kg, c)100g pack sizes.
- Distribution
- U.S. Nationwide.
- Quantity
- 217 units
- Recall started
- March 1, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0447-2024
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Class II Completed
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.
Reason: Failed Stability Specifications
Lots, distribution and details
- Lots / codes
- Lot #: H22212-FSV, Exp: 11/21/2024 1.0 kg pack size.
- Distribution
- U.S. Nationwide.
- Quantity
- 26 units
- Recall started
- March 1, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0446-2024
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Class II Completed
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, I…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- 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
- Lots / codes
- Batch number: D608951C, exp 4/10/2025
- Distribution
- Nationwide USA
- Quantity
- 700 vials
- Recall started
- March 12, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0445-2024
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Class I Terminated
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.
Reason: Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Lots, distribution and details
- Lots / codes
- Lot: AW0221A Exp. 08/30/2025
- Distribution
- US Nationwide.
- Quantity
- 153 cartons
- Recall started
- March 28, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0444-2024
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Class III Terminated
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
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot M23011A; Exp. 12/2024
- Distribution
- U.S. Nationwide
- Quantity
- 1,003 bottles
- Recall started
- March 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0443-2024
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Class I Terminated
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 P…
Reason: Superpotent Drug: Due to overfilling of drug powder
Lots, distribution and details
- Product
- 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
- Lots / codes
- Lot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 821 bottles
- Recall started
- March 21, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0442-2024
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Class III Completed
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
Reason: Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Lots, distribution and details
- Lots / codes
- Lot #, 1990305, Exp 08-31-2025
- Distribution
- Nationwide in the USA
- Quantity
- 3,480 30-count bottles
- Recall started
- March 27, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0441-2024
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 November 4, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.