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.
1,094 recalls
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Class II Ongoing
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Lots, distribution and details
- Lots / codes
- Lot 8290V, Exp: 10-2023
- Distribution
- Product was distributed Nationwide.
- Quantity
- 54,222 bottles
- Recall started
- May 3, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0773-2023
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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 II Ongoing
Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Lots, distribution and details
- Lots / codes
- SKUs a) 0999841; b) 0916071 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Distribution
- Nationwide within the United States
- Quantity
- Pending
- Recall started
- March 31, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0566-2023
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Class II Ongoing
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Lots, distribution and details
- Product
- Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
- Lots / codes
- SKUs 0902867 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- March 31, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0565-2023
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Class II Ongoing
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Lots, distribution and details
- Lots / codes
- SKU 0901839 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Distribution
- Nationwide within the United States
- Quantity
- Pending
- Recall started
- March 31, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0564-2023
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Class II Ongoing
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Lots, distribution and details
- Lots / codes
- SKUs a) 0901458; b) 0913023; c) 0999259 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Distribution
- Nationwide within the United States
- Quantity
- Pending.
- Recall started
- March 31, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0563-2023
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Class II Ongoing
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
Reason: Out of specification (OOS) for Spectroscopic Identification test by IR.
Lots, distribution and details
- Product
- Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
- Lots / codes
- Lot #22143120, Exp. Date: June 2024
- Distribution
- Nationwide in the USA
- Quantity
- 135 bottles
- Recall started
- March 17, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0539-2023
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Class II Ongoing
Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8.
Reason: CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Lots, distribution and details
- Lots / codes
- Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024
- Distribution
- Nationwide in the USA
- Quantity
- 69,615 bottles
- Recall started
- April 6, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0537-2023
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Class III Ongoing
MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Lots, distribution and details
- Product
- MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02
- Lots / codes
- Lot W054586A, EXP 03/2026
- Distribution
- Nationwide in the USA
- Quantity
- 1,926 Bottles
- Recall started
- March 8, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0532-2023
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Class II Ongoing
Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
Reason: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Lots, distribution and details
- Lots / codes
- Lots: 03FE2319 Exp. 2/28/25, 13MY2217 Exp. 5/31/23
- Distribution
- Nationwide in the USA
- Quantity
- 9 bottles
- Recall started
- March 22, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0509-2023
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Class II Ongoing
Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
Reason: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Lots, distribution and details
- Lots / codes
- Lots: a) 03FE2318, Exp. 8/31/24; b) 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, Exp. 8/31/24; 17FE2203, 12AP2204, 17MA2205, Exp. 3/31/23; 21JU2206, 22JU2220, 12JY2206, Exp. 5/31/23; 10AU2209, Exp. 6/30/23; 14DE2215, Exp. 9/30/24; 05JA2304, 27JA2301, Exp. 11/30/24.
- Distribution
- Nationwide in the USA
- Quantity
- 349 bottles
- Recall started
- March 22, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0508-2023
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Class II Ongoing
Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.
Reason: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Lots, distribution and details
- Lots / codes
- Lot: 11AP2219 Exp. 4/30/23
- Distribution
- Nationwide in the USA
- Quantity
- 20 bottles
- Recall started
- March 22, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0507-2023
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Class II Ongoing
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.
Reason: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Lots, distribution and details
- Product
- Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.
- Lots / codes
- Lot #s: 22142448, 22142449, 22142450, Exp 5/2024; 22143845, Exp 7/2024.
- Distribution
- Nationwide in the USA.
- Quantity
- 12,804 bottles
- Recall started
- March 14, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0534-2023
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Class II Ongoing
Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.
Reason: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Lots, distribution and details
- Lots / codes
- Lot #s: 22142462, 22142463, 22142464, Exp 5/2024; 22143000, 22143001, 22143002, Exp 6/2024.
- Distribution
- Nationwide in the USA.
- Quantity
- 13,560 bottles
- Recall started
- March 14, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0533-2023
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Class I Ongoing
Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.
Reason: Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Lots, distribution and details
- Lots / codes
- Batch # H29, Exp. Date 11/30/2023
- Distribution
- Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
- Quantity
- 50,000 tubes
- Recall started
- February 24, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0488-2023
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Class I Ongoing
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04.
Reason: Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Lots, distribution and details
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA
- Quantity
- 500 bottles
- Recall started
- February 14, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0455-2023
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Class III Ongoing
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
Reason: Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Lots, distribution and details
- Product
- Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
- Lots / codes
- Lot: 081031A, Exp 2/28/2023
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 45,117 Bottles
- Recall started
- January 30, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0265-2023
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Class II Ongoing
Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel – Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
Reason: CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 202161, 202322, 202323, 202794, 202858, 203188, 203238, 203240, 203722 203723, 203724, 203725, 204852
- Distribution
- Nationwide in the USA
- Quantity
- 106 bottles
- Recall started
- January 17, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0164-2023
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Class II Ongoing
Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel – Belgium, 1 Reagent Lane, Fair…
Reason: CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Lots, distribution and details
- Product
- Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel – Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
- Lots / codes
- Lot Numbers: 202160, 202162, 202324, 202368, 202369, 202593, 202594, 202835, 202862, 202863, 202865, 202836, 202864, 203061, 203098, 203099, 203100, 203101, 203102, 203236, 203237, 203239, 203337, 203338, 203335, 203336
- Distribution
- Nationwide in the USA
- Quantity
- a) 1077 bottles, b) 52 cases
- Recall started
- January 17, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0163-2023
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Class II Ongoing
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05
- Lots / codes
- Lot: 1D94A, EXP 3/31/2023; 1E35A, EXP 4/30/2023; 2A06A, EXP 12/31/2023
- Distribution
- Nationwide in the USA
- Quantity
- 91,692 bottles
- Recall started
- October 13, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0158-2023
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Class II Ongoing
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15
- Lots / codes
- Lot: 0L53A, EXP 10/31/2022; 1J49A, EXP 8/31/2023;
- Distribution
- Nationwide in the USA
- Quantity
- 23,026 bottles
- Recall started
- October 13, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0154-2023
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Class II Ongoing
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12
- Lots / codes
- Lot: 0L42A, 0L50A, EXP 10/31/2022; 1C64A, 1C76A, EXP 2/28/2023; 1G53A, EXP 6/30/2023; 1J26A, 1J25A, 1J48A, 1J54A, EXP 8/31/2023
- Distribution
- Nationwide in the USA
- Quantity
- 267,678 bottles
- Recall started
- October 13, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0153-2023
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Class II Ongoing
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05
Reason: CGMP Deviations:
Lots, distribution and details
- Lots / codes
- Lot: 11B26A, EXP 1/31/2023; 1H02A, EXP 7/31/2023;
- Distribution
- Nationwide in the USA
- Quantity
- 65,006 bottles
- Recall started
- October 13, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0146-2023
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Class II Ongoing
Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20
Reason: Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Lots, distribution and details
- Product
- Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20
- Lots / codes
- Lot # AC22004, Expiry: 08/2023
- Distribution
- Nationwide in the USA
- Quantity
- 45,250 vials
- Recall started
- December 28, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0095-2023
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.