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
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 23OCT013, Exp. Date 10/10/2024
- Distribution
- Nationwide within the United States
- Quantity
- 18,980 vials
- Recall started
- May 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0515-2024
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Class II Ongoing
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, N…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01
- Lots / codes
- Lot #: 23MAY008, Exp. Date 5/1/24; 23OCT011, Exp. Date 10/26/24; 23NOV035, Exp. Date 12/6/24; 24JAN024, Exp. Date 1/14/25
- Distribution
- Nationwide within the United States
- Quantity
- 38,060 vials
- Recall started
- May 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0514-2024
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Class II Ongoing
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 23MAY016, Exp. Date 5/8/24; 23JUL016, Exp. Date 7/10/24; 23AUG034, Exp. Date 8/16/24; 23DEC014, Exp. Date 12/10/24
- Distribution
- Nationwide within the United States
- Quantity
- 39,700 vials
- Recall started
- May 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0513-2024
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Class II Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 23APR033, Exp. Date 5/1/24; 23JUN001, Exp. Date 6/5/24
- Distribution
- Nationwide within the United States
- Quantity
- 14,180 vials
- Recall started
- May 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0512-2024
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Class I Ongoing
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
Reason: Labeling: Label Mix-up – product labeled as tirzepatide contains testosterone cypionate
Lots, distribution and details
- Lots / codes
- Lot #: 748127, Exp 9/24/2024
- Distribution
- USA Nationwide
- Quantity
- 751 vials
- Recall started
- April 20, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0511-2024
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Class II Ongoing
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52
Reason: Lack of Assurance of Sterility: Leaking vials
Lots, distribution and details
- Lots / codes
- Lot #: G3000010, Exp. Date 11/2025
- Distribution
- Nationwide within the United States
- Quantity
- 13,880 vials
- Recall started
- May 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0510-2024
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Class II Terminated
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Reason: Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Lots, distribution and details
- Lots / codes
- Lot #: 3618858, 3618873, Exp. Date 01/31/2026
- Distribution
- Nationwide within the United States
- Quantity
- Lot:3618858 = 105,759; Lot:3618873 =90,359
- Recall started
- May 20, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0509-2024
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Class I Completed
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Reason: Labeling: Label mix-up – ephedrine syringes mislabeled as phenylephrine.
Lots, distribution and details
- Lots / codes
- Lot #: 240310003D, Exp 6/4/2024
- Distribution
- CO, GA, PA, SD, WA
- Quantity
- —
- Recall started
- April 29, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0508-2024
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Class II Terminated
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
Reason: Subpotent product in addition to having out-of-specification results for impurities.
Lots, distribution and details
- Product
- Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
- Lots / codes
- Lot #: 23061L1C0, Exp 1/31/2025
- Distribution
- USA Nationwide
- Quantity
- 2,352 vials
- Recall started
- May 13, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0507-2024
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Class II Ongoing
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 3…
Reason: Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Lots, distribution and details
- Product
- Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
- Lots / codes
- Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
- Distribution
- Nationwide within the United States
- Quantity
- 5,578 units
- Recall started
- April 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0506-2024
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Class II Ongoing
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots, distribution and details
- Lots / codes
- Lot #: J2022G, Exp: 01/01/2025
- Distribution
- Product distributed to CA, FL, OK, KS and CT
- Quantity
- 66 bottles of 30 tablets
- Recall started
- May 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0505-2024
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Class III Ongoing
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot H2200493; Exp 6/30/2025
- Distribution
- US Nationwide.
- Quantity
- 1,176 bottles
- Recall started
- May 1, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0504-2024
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Class II Terminated
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 430…
Reason: Lack of Assurance of Sterility.
Lots, distribution and details
- Product
- niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10
- Lots / codes
- Lot #: 23087N0C0, Exp. Date 11/2024
- Distribution
- UT only
- Quantity
- 4,136 cartons (10 vials in each carton)
- Recall started
- May 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0503-2024
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Class III Ongoing
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
Reason: Failed Release Testing: Out of specification for particulate matter test.
Lots, distribution and details
- Lots / codes
- Lot #: HAD3383A, Exp 8/31/2024
- Distribution
- TX, PA
- Quantity
- 35,069 bottles
- Recall started
- April 22, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0502-2024
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Class II Ongoing
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9
Reason: Microbial Contamination of Non-Sterile Products – Presence of Acetobacter nitrogenifigens bacteria
Lots, distribution and details
- Lots / codes
- Lot #: A81834, Exp 1/31/2026
- Distribution
- USA Nationwide
- Quantity
- 24840
- Recall started
- May 1, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0501-2024
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Class II Ongoing
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
Reason: Microbial Contamination of Non-Sterile Products – Presence of Acetobacter nitrogenifigens bacteria
Lots, distribution and details
- Lots / codes
- Lot #: A81506, Exp 12/31/2025
- Distribution
- USA Nationwide
- Quantity
- 120830
- Recall started
- May 1, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0500-2024
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Class II Ongoing
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
Reason: Presence of Particulate Matter: Potential for black particulates in the drug product.
Lots, distribution and details
- Product
- MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
- Lots / codes
- Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 14,360 vials
- Recall started
- April 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0499-2024
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Class II Ongoing
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Hi…
Reason: Presence of foreign substance: plastic-like substance.
Lots, distribution and details
- Product
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44
- Lots / codes
- Lot #: BLK2304A, Exp. 07/31/2025
- Distribution
- USA Nationwide
- Quantity
- 1,048 bottles
- Recall started
- May 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0498-2024
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Class II Terminated
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Man…
Reason: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Lots, distribution and details
- Product
- Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
- Lots / codes
- Lot # F305292, Exp 8/30/2025
- Distribution
- USA nationwide
- Quantity
- 17,040 bottles
- Recall started
- April 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0497-2024
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Class II Terminated
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Man…
Reason: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Lots, distribution and details
- Product
- Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04
- Lots / codes
- Lot # F305442, Exp 8/30/2025
- Distribution
- USA nationwide
- Quantity
- 17,070 bottles
- Recall started
- April 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0496-2024
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Class II Completed
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: F135, Exp. Date March 2025; F146, Exp. Date April , 2025; G103, Exp. Date January 2026; G194, Exp. Date September 2026
- Distribution
- Product was distributed nationwide within the United States
- Quantity
- 5,247 glass jars
- Recall started
- April 12, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0495-2024
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Class I Terminated
Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
Reason: Marketed Without An Approved NDA/ANDA
Lots, distribution and details
- Lots / codes
- Lot 2108; EXP 10/31/2024
- Distribution
- Distribution worldwide via amazon.com
- Quantity
- 5 boxes
- Recall started
- April 22, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0494-2024
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Class II Ongoing
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-3893…
Reason: Out of specification for assay
Lots, distribution and details
- Product
- Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01
- Lots / codes
- Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
- Distribution
- Nationwide within the United States
- Quantity
- 11,016 vials
- 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-0493-2024
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Class II Ongoing
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, E…
Reason: Discoloration: Dotted and yellow spots on tablets
Lots, distribution and details
- Product
- Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
- Lots / codes
- Lot #s: a) CZB124001B, CZB124002B, CZB124003B, Exp. 12/31/2025; b) CZB124001A, CZB124003A, Exp. 12/31/2025.
- Distribution
- Nationwide in the USA
- Quantity
- 6909 bottles
- Recall started
- April 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0492-2024
-
Class II Ongoing
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, E…
Reason: Discoloration: Dotted and yellow spots on tablets
Lots, distribution and details
- Product
- Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
- Lots / codes
- Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.
- Distribution
- Nationwide in the USA
- Quantity
- 6696 bottles
- Recall started
- April 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0491-2024
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 3, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.