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
Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
Reason: Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Lots, distribution and details
- Product
- Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
- Lots / codes
- Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24
- Distribution
- Nationwide within the United States
- Quantity
- 335,940 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-0390-2024
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Class III Terminated
Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20
Reason: Cross Contamination with Other Products:(mycophenolate mofetil).
Lots, distribution and details
- Lots / codes
- Lot #: M23172A, Exp 01/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 3,940 1000-count bottles
- Recall started
- March 4, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0389-2024
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Class II Terminated
Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.
Reason: Failed Stability Specifications: Out of specification for blend uniformity.
Lots, distribution and details
- Lots / codes
- Lot #s: SFBG024, SFBG025, Exp. 05/31/2024
- Distribution
- Puerto Rico, TN, RI
- Quantity
- 118,080 bottles
- Recall started
- February 9, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0388-2024
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Class II Ongoing
Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 3318…
Reason: Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Lots, distribution and details
- Product
- Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12
- Lots / codes
- Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025
- Distribution
- Nationwide within the United States
- Quantity
- 2345 boxes
- Recall started
- February 16, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0387-2024
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Class II Ongoing
Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44
Reason: Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Lots, distribution and details
- Lots / codes
- Lot #: 223002, Exp. Date 10/2025; 223063, Exp. Date 02/2026
- Distribution
- Nationwide within the United States
- Quantity
- 9831 bottles
- Recall started
- February 16, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0386-2024
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Class II Terminated
Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470…
Reason: Failed Stability Specification: Water determination was found not complying with specification.
Lots, distribution and details
- Product
- Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01.
- Lots / codes
- Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.
- Distribution
- Nationwide
- Quantity
- 1160 VIALS
- Recall started
- February 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0385-2024
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Class II Ongoing
hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within Expiry
- Distribution
- Product distributed Nationwide in the USA
- Quantity
- 46,621 bottles
- Recall started
- February 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0384-2024
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Class II Ongoing
TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: R608, Exp:04-21-2024, R609, Exp: 05-19-2024, R610, Exp: 07-28-2024, R611, Exp: 10-6-2024; R612, Exp: 02-02-2025, R613, Exp: 10-12-2025, R614, Exp: 11-02-2025
- Distribution
- Product distributed Nationwide in the USA
- Quantity
- 106,704 bottles
- Recall started
- February 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0383-2024
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Class II Ongoing
TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: P516, Exp: 03-24-2024, P517, Exp: 08-31-2024, P518, Exp:10-20-2024, P519, Exp: 03-09-2025, P520, Exp: 10-19-2025, P521, Exp: 11-09-2025, P522, Exp: 11-16-2025, P523, Exp: 01-18-2026, P524, Exp: 04-26-2026, P525, Exp: 05-10-2026, P526, Exp: 06-07-2026
- Distribution
- Product distributed Nationwide in the USA
- Quantity
- 139,656 bottles
- Recall started
- February 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0382-2024
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Class II Ongoing
TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: G806, Exp: 06-01-2025, G807, Exp: 10-27-2026.
- Distribution
- Product distributed Nationwide in the USA
- Quantity
- 19,344 bottles
- Recall started
- February 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0381-2024
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Class II Ongoing
TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: F404, Exp: 05-14-2025, F405, Exp: 08-24-2025, F406, Exp: 10-11-2026.
- Distribution
- Product distributed Nationwide in the USA
- Quantity
- 24,216 bottles
- Recall started
- February 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0380-2024
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Class II Ongoing
TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: E206, Exp: 09-21-2025
- Distribution
- Product distributed Nationwide in the USA
- Quantity
- 10,536 bottles
- Recall started
- February 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0379-2024
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Class II Ongoing
TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: D101, Exp: 07-01-2024, D102, Exp: 12-01-2024, D103, Ep: 04-13-2025
- Distribution
- Product distributed Nationwide in the USA
- Quantity
- 47,832 bottles
- Recall started
- February 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0378-2024
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Class II Ongoing
TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: C303, Exp: 07-27-2025
- Distribution
- Product distributed Nationwide in the USA
- Quantity
- 9,936 bottles
- Recall started
- February 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0377-2024
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Class II Ongoing
TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: B905, Exp: 07-13-2025
- Distribution
- Product distributed Nationwide in the USA
- Quantity
- 7,248 bottles
- Recall started
- February 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0376-2024
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Class II Ongoing
TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: A703, Exp: 02-15-2026, A704, Exp: 03-22-2026, A705, Exp: 04-05-2026
- Distribution
- Product distributed Nationwide in the USA
- Quantity
- 30,240 bottles
- Recall started
- February 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0375-2024
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Class II Terminated
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Reason: Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Lots, distribution and details
- Product
- Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
- Lots / codes
- Lot #: 435019, Exp. Date 11/2024
- Distribution
- Product was distributed nationwide within the United States
- Quantity
- 5,476 bottles
- Recall started
- March 5, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0374-2024
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Class II Terminated
Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
Reason: cGMP Deviations: Products were stored outside the drug label specifications.
Lots, distribution and details
- Lots / codes
- 567951
- Distribution
- Product was distributed to three direct accounts in NM, AZ and UT.
- Quantity
- 70 vials
- Recall started
- February 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0373-2024
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Class II Terminated
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
Reason: cGMP Deviations: Products were stored outside the drug label specifications.
Lots, distribution and details
- Lots / codes
- 519644
- Distribution
- Product was distributed to three direct accounts in NM, AZ and UT.
- Quantity
- 70 vials
- Recall started
- February 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0372-2024
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Class II Terminated
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
Reason: cGMP Deviations: Products were stored outside the drug label specifications.
Lots, distribution and details
- Lots / codes
- 1064081
- Distribution
- Product was distributed to three direct accounts in NM, AZ and UT.
- Quantity
- 70 vials
- Recall started
- February 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0371-2024
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Class II Terminated
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
Reason: Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Lots, distribution and details
- Lots / codes
- Lot #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.
- Distribution
- Nationwide in the USA
- Quantity
- 22,752 bags
- Recall started
- March 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0370-2024
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Class II Ongoing
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T.…
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots, distribution and details
- Product
- Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01.
- Lots / codes
- Lot #: DNE0894A, Exp 07/31/2025
- Distribution
- Nationwide
- Quantity
- 7,488 bottles
- Recall started
- March 4, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0369-2024
-
Class II Ongoing
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T.…
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots, distribution and details
- Product
- Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.
- Lots / codes
- Lot #s: DNE0865A, DNE0866A, Exp 06/30/2025
- Distribution
- Nationwide
- Quantity
- 47,520 bottles
- Recall started
- March 4, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0368-2024
-
Class III Terminated
Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
Reason: Failed Dissolution Specifications: results slightly under spec at at 9-months.
Lots, distribution and details
- Lots / codes
- Lot #: a)22K012, 22K013A, Exp: 04/30/2024; 23A001, 23A002A, Exp: 07/31/2024; 23D006, 23D007A, 23D007C, Exp:10/31/2024; b)22K013B, Exp: 04/30/2024; 23A002B, Exp:07/31/2024; 23D007B, Exp: 10/31/2024.
- Distribution
- USA Nationwide
- Quantity
- 54, 131 bottles
- Recall started
- February 9, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0367-2024
-
Class II Ongoing
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lot #: 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025
- Distribution
- OH, TN, LA, MS
- Quantity
- 10,080 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-0366-2024
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.