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 III Ongoing
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
Reason: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Lots, distribution and details
- Lots / codes
- Lot #: 119874; Exp 06/30/2025
- Distribution
- Nationwide in the U.S. and Puerto Rico
- Quantity
- 11,750 bottles
- Recall started
- February 20, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0365-2024
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Class III Ongoing
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
Reason: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Lots, distribution and details
- Lots / codes
- Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025
- Distribution
- Nationwide in the U.S. and Puerto Rico
- Quantity
- 45,875 bottles
- Recall started
- February 20, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0364-2024
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Class II Ongoing
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Lots, distribution and details
- Product
- Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
- Lots / codes
- Lot #:2331104, Exp:9-Mar-24; 2331137, Exp: 3-Mar-24; 2331196, Exp: 11-Mar-24; 2331264, Exp: 6-Apr-24; 2331282, Exp: 18-Apr-24; 2331464, Exp: 8-May-24; 2331481, Exp: 16-May-24; 2331500, Exp: 20-May-24.
- Distribution
- Nationwide in the USA
- Quantity
- 40,890 vials
- Recall started
- February 20, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0363-2024
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Class II Ongoing
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Lots, distribution and details
- Lots / codes
- Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24.
- Distribution
- Nationwide in the USA
- Quantity
- 10,020 vials
- Recall started
- February 20, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0362-2024
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Class II Ongoing
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Lots, distribution and details
- Lots / codes
- Lot #:2331147, Exp:6-Mar-24; 2331180, Exp: 21-Mar-24; 2331256, Exp: 2-Apr-24; 2331279, Exp: 3-Apr-24; 2331283, Exp: 7-Apr-24; 2331345, Exp: 20-Apr-24; 2331422, Exp: 27-Apr-24; 2331563, Exp: 29-May-24.
- Distribution
- Nationwide in the USA
- Quantity
- 40,090 vials
- Recall started
- February 20, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0361-2024
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Class II Terminated
PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471
Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Lots, distribution and details
- Lots / codes
- Lot #: 266029, Exp. 03/27/2024.
- Distribution
- Nationwide in the US and Puerto Rico
- Quantity
- 480 cases
- Recall started
- February 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0360-2024
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Class II Terminated
7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033
Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Lots, distribution and details
- Lots / codes
- Lot #s: 266029, Exp. 03/27/2024; 255917, Exp. 06/23/2024; 261521, Exp. 06/27/2024.
- Distribution
- Nationwide in the US and Puerto Rico
- Quantity
- 1,282 cases
- Recall started
- February 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0359-2024
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Class II Terminated
7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033
Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Lots, distribution and details
- Lots / codes
- Lot #: 251176, Exp. 06/23/2024.
- Distribution
- Nationwide in the US and Puerto Rico
- Quantity
- 3 cases
- Recall started
- February 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0358-2024
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Class II Terminated
PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Lots, distribution and details
- Lots / codes
- Lot #: 265029, Exp. 03/27/2024; 273759, Exp. 11/29/2024.
- Distribution
- Nationwide in the US and Puerto Rico
- Quantity
- 274 cases
- Recall started
- February 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0357-2024
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Class II Terminated
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX…
Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Lots, distribution and details
- Product
- PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
- Lots / codes
- Lot #s: a) 263647, Exp. 06/09/2024; 271382, Exp. 01/18/2025; b) 261675, Exp. 04/09/2024; 263647, Exp. 06/09/2024; 272766, Exp.02/15/2025.
- Distribution
- Nationwide in the US and Puerto Rico
- Quantity
- 1,450 cases
- Recall started
- February 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0356-2024
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Class II Completed
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2…
Reason: Subpotent Drug: Out of specification for assay
Lots, distribution and details
- Product
- Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.
- Lots / codes
- Lot #0013R; Exp. 01/2026
- Distribution
- Nationwide
- Quantity
- 3,600 cartons
- Recall started
- February 2, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0355-2024
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Class II Ongoing
Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: A2G01, A2G02, Exp. Date Jun-24; A3F08, A3F09, Exp. Date May-25; A3J17, A3J18, Exp. Date Sep-25
- Distribution
- Nationwide within the United States
- Quantity
- 355,120 units
- Recall started
- January 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0354-2024
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Class II Ongoing
CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, U…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141
- Lots / codes
- Lot #: A2F03, Exp. Date May-24; A2I02, Exp. Date Aug-24; A2L02, Exp. Date Nov-24; A3C04, Exp. Date Feb-25; A3H04, Exp. Date Jul-25
- Distribution
- Nationwide within the United States
- Quantity
- 159,334 units
- Recall started
- January 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0353-2024
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Class II Ongoing
Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: A2D08, Exp. Date Mar-24; A2F02, Exp. Date May-24; A2I03, Exp. Date Aug-24; A2L03, A2L04, Exp. Date Nov-24; A3C03, A3C05, Exp. Date Feb-25 A3H01, A3H03, Exp. Date Jul-25
- Distribution
- Nationwide within the United States
- Quantity
- 355,633 units
- Recall started
- January 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0352-2024
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Class II Ongoing
Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: A2E01, Exp. Date Apr-24; A2L05, Exp. Date Nov-24, A3B01, Exp. Date Jan-25; A3C01, Exp. Date Feb-25
- Distribution
- Nationwide within the United States
- Quantity
- 315,842 units
- Recall started
- January 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0351-2024
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Class II Ongoing
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ…
Reason: Failed Dissolution Specifications: Out of specification for dissolution.
Lots, distribution and details
- Product
- Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
- Lots / codes
- Lot #s: MHD0606A, MHD0612A, Exp. 04/30/2024; MHD0613A, MHD0652A, MHD0657A, MHD0672A, MHD0673A, Exp. 05/31/2024; MHD0767A, MHD0768A, MHD0769A, MHD0785A, MHD0799A, MHD0800A, MHD0801A, Exp. 06/30/2024; MHD0827A, MHD0828A, MHD0875A, MHD0876A, MHD0898A, MHD0901A, Exp. 07/31/2024; MHD1081A, MHD1082A, MHD1087A Exp. 09/30/2024.
- Distribution
- Nationwide in the U.S.
- Quantity
- 54,960 bottles
- Recall started
- February 5, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0350-2024
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Class II Ongoing
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-…
Reason: CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Lots, distribution and details
- Product
- Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15
- Lots / codes
- Lot #: TX5275, Exp. Date: 10/31/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 59,712 bottles
- Recall started
- February 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0349-2024
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Class II Ongoing
Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01
Reason: CGMP Deviations: Out of specification for residual solvents.
Lots, distribution and details
- Lots / codes
- ZOAG043
- Distribution
- Nationwide in the USA
- Quantity
- 24,768 bottles
- Recall started
- February 12, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0348-2024
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Class II Terminated
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807…
Reason: CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Lots, distribution and details
- Product
- CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.
- Lots / codes
- Lot: 7001796, Exp 05/31/2025
- Distribution
- Nationwide in the US
- Quantity
- 42 units
- Recall started
- February 12, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0347-2024
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Class I Completed
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3
Reason: Chemical Contamination; presence of benzene.
Lots, distribution and details
- Lots / codes
- Lot # 0H50545, Exp. date 07/31/24; 1G50645, Exp. date 06/30/25
- Distribution
- Product was distributed nationwide and to 4 foreign accounts. Guaynabo, Puerto Rico; Georgetown, Guyana; Baghdad, Iraq; Accra, Ghana.
- Quantity
- 59,644 cans
- Recall started
- February 1, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0346-2024
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Class I Ongoing
Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Lots, distribution and details
- Lots / codes
- Lot #: 2107, Exp. Date 10/31/2024.
- Distribution
- Product distributed nationwide within the United States.
- Quantity
- 5500 boxes
- Recall started
- February 6, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0345-2024
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Class I Ongoing
SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Lots, distribution and details
- Lots / codes
- Lot #: 2108, Exp. Date 10/31/2024.
- Distribution
- Product distributed nationwide within the United States.
- Quantity
- 11500 boxes
- Recall started
- February 6, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0344-2024
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Class I Ongoing
Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Lots, distribution and details
- Lots / codes
- Lot #: BTH:230551, Exp. Date 12.05.2026; BTH:230571, Exp. Date 14.05.2026
- Distribution
- Product distributed nationwide within the United States.
- Quantity
- 7000 boxes
- Recall started
- February 6, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0343-2024
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Class II Completed
Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Lots, distribution and details
- Lots / codes
- Original Lot # 64103, exp. date 11/24 Repackaged Lot # 39747, exp. date 01/26
- Distribution
- USA nationwide.
- Quantity
- 1,099 Single Dose Vials
- Recall started
- January 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0342-2024
-
Class II Ongoing
Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01
Reason: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Lots, distribution and details
- Lots / codes
- Lot #: 22TRP01-F2, Exp 6/30/2024
- Distribution
- USA nationwide
- Quantity
- 421 vials involved in this recall (2,448 vials distributed)
- Recall started
- February 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0341-2024
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.