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.
311 recalls
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Class I Ongoing
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton);…
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lots, distribution and details
- Product
- LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle)
- Lots / codes
- ALL LOTS
- Distribution
- Nationwide in the USA
- Quantity
- 28477 cartons
- Recall started
- October 31, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0134-2024
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Class I Ongoing
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lots, distribution and details
- Lots / codes
- ALL LOTS
- Distribution
- Nationwide in the USA
- Quantity
- 119,871 bottles
- Recall started
- October 31, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0133-2024
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Class I Ongoing
LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lots, distribution and details
- Lots / codes
- ALL LOTS
- Distribution
- Nationwide in the USA
- Quantity
- 21,802 bottles
- Recall started
- October 31, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0132-2024
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Class I Ongoing
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela P…
Reason: Presence of Particulate Matter: Silicone
Lots, distribution and details
- Product
- Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4).
- Lots / codes
- Lot # 10001088 exp 07/31/2024
- Distribution
- Nationwide
- Quantity
- 23,425 vials
- Recall started
- October 18, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0117-2024
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Class I Ongoing
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20×50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25×50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-50…
Reason: Presence of Particulate Matter: Silicone
Lots, distribution and details
- Product
- 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20×50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25×50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20×50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
- Lots / codes
- a) P0001429, EXP 11/30/2023 b) P0001900, P0001902, EXP 08/31/2024; P0001903, P0001909, P0001945, EXP 09/30/2024; P0002002, EXP 11/30/2024; P0002052, EXP 12/31/2024 c) P0001912, EXP 08/31/2024
- Distribution
- Nationwide
- Quantity
- 355,220 vials
- Recall started
- October 18, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0116-2024
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Class I Terminated
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24
Reason: Presence of Particulate Matter: identified as glass.
Lots, distribution and details
- Lots / codes
- Lot#: GJ5007, Exp. 8/1/2024
- Distribution
- Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
- Quantity
- 24,900 vials
- Recall started
- October 2, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0100-2024
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Class II Terminated
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lot # HM03221A, Exp. date 12/31/2023
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 9,263 100-count bottles
- Recall started
- October 27, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0090-2024
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Class III Ongoing
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
Reason: Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Lots, distribution and details
- Lots / codes
- Lot # 1187435 exp date: 02/2024
- Distribution
- Distributed in the US. No government or foreign consignees.
- Quantity
- 864 cartons
- Recall started
- October 17, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0088-2024
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Class II Terminated
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
Reason: Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Lots, distribution and details
- Lots / codes
- Lot # C2305569, Exp. date 03/31/2026
- Distribution
- Nationwide
- Quantity
- 1,656 bottles
- Recall started
- October 13, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0086-2024
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Class II Terminated
Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-39…
Reason: Failed Impurities/Degradation Specifications.
Lots, distribution and details
- Product
- Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-590-88
- Lots / codes
- Lot #: DNC2204A, Exp. Date 11/2023
- Distribution
- Nationwide within the United States
- Quantity
- 2304 Bottles
- Recall started
- October 20, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0084-2024
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Class II Terminated
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396…
Reason: Failed Impurities/Degradation Specifications.
Lots, distribution and details
- Product
- Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88
- Lots / codes
- Lot #: DND0058A, Exp. Date 12/2023
- Distribution
- Nationwide within the United States
- Quantity
- 7392 Bottles
- Recall started
- October 20, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0083-2024
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Class III Terminated
VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.
Reason: Labeling: Not Elsewhere Classified
Lots, distribution and details
- Lots / codes
- Lot#: 2330792, Exp. 12/17/23; 2330801, Exp. 12/26/23; 2330821, 10/15/23; 2330823, Exp. 10/21/23; 2330825, Exp. 10/27/23; 2330846, Exp. 10/28/23; 2330847, Exp. 11/03/23; 2330856, 11/17/23; 2330858, Exp. 12/03/23; 2330860, 12/15/23; 2330866, Exp. 12/29/23; 2331053, Exp. 01/13/24.
- Distribution
- USA Nationwide
- Quantity
- 25,908 IV bags
- Recall started
- October 4, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0072-2024
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Class III Terminated
VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.
Reason: Labeling: Not Elsewhere Classified
Lots, distribution and details
- Lots / codes
- Lot#: 2330781, Exp. 10/19/23; 2330791, Exp. 10/29/23; 2330795, Exp. 11/02/23; 2330800, Exp. 11/09/23; 2330807, Exp. 11/11/23; 2330812, Exp. 11/16/23; 2330816, Exp. 11/19/23; 2330822, 10/20/23; 2330897,11/23/23; 2330899, 11/25/23; 2330901, 11/26/23; 2330918, 11/30/23; 2330943, 01/12/24; 2331050, 01/14/24; 2331064, 01/21/24; 2331102, Exp. 01/25/24.
- Distribution
- USA Nationwide
- Quantity
- 33,480 IV Bags
- Recall started
- October 4, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0071-2024
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Class III Terminated
Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70
Reason: Labeling: Not Elsewhere Classified
Lots, distribution and details
- Lots / codes
- Lot#: 2330956, Exp. 10/23/2023; 2330964, Exp. 10/24/2023; 2331014, Exp. 11/6/2023; 2331033, Exp. 11/8/2023
- Distribution
- USA Nationwide
- Quantity
- 6,276 IV bags
- Recall started
- October 4, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0070-2024
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Class I Ongoing
TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628
Reason: Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Lots, distribution and details
- Lots / codes
- Lot # PA3083011, Exp 3/31/2025
- Distribution
- Nationwide in the US
- Quantity
- 5,316 bottles
- Recall started
- September 8, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0046-2024
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Class II Ongoing
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Di…
Reason: Defective Delivery System
Lots, distribution and details
- Product
- Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12
- Lots / codes
- Lot #: 220151, 220152, 220153, Exp. Date 11/2024
- Distribution
- Nationwide within the United States
- Quantity
- 2844 units
- Recall started
- June 22, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0941-2023
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Class II Ongoing
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
Reason: CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Lots, distribution and details
- Lots / codes
- Lot #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023
- Distribution
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Quantity
- 400,008 bottles total for all products
- Recall started
- January 30, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0922-2023
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Class I Ongoing
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Lots, distribution and details
- Lots / codes
- Lot #: PCMH001, PCMH002, PCMH005, PCMH007, Exp. date NOV-2023
- Distribution
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Quantity
- 400,008 bottles total for all products
- Recall started
- January 30, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0921-2023
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Class II Ongoing
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Reason: CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Lots, distribution and details
- Lots / codes
- Lot #: PCMH009, PCMH010, PCMH011, PCMH012, PCMH013, PCMH014, PCMH015, PCMH016, exp. date Nov-2023; PCMI001, PCMI002, PCMI003, PCMI004, PCMI006, PCMI 07, PCMI 008, Exp. date AUG-2024; PCMJ003, PCMJ007, PCMJ016, Exp. date MAR-2025
- Distribution
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Quantity
- 400,008 bottles total for all products
- Recall started
- January 30, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0920-2023
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Class I Ongoing
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Lots, distribution and details
- Lots / codes
- Lot #: PCMI005, Exp. date AUG-2024; PCMJ001, PCMJ002, PCMJ004, PCMJ005, PCMJ006, PCMJ008, PCMJ009, PCMJ010, PCMJ011, PCMJ012, PCMJ013, PCMJ014, PCMJ015, Exp. date MAR-2025
- Distribution
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Quantity
- 400,008 bottles total for all products
- Recall started
- January 30, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0919-2023
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Class II Ongoing
Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0846-2023
-
Class II Ongoing
Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0845-2023
-
Class II Ongoing
Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0844-2023
-
Class II Ongoing
DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0801-2023
-
Class II Ongoing
Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0800-2023
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 1, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.