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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 3,261–3,280 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Discoloration
Recall initiated
July 25, 2022
Reported by FDA
November 30, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO.

by Adam's Polishes LLC

Reason
CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Recall initiated
November 5, 2022
Reported by FDA
November 23, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO.

by Adam's Polishes LLC

Reason
Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
Recall initiated
November 5, 2022
Reported by FDA
November 23, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.

by Nephron Sterile Compounding Center LLC

Reason
CGMP Deviations: Potential for cross contamination due to product carry over.
Recall initiated
November 10, 2022
Reported by FDA
November 23, 2022
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.

by Nephron Sterile Compounding Center LLC

Reason
CGMP Deviations: Potential for cross contamination due to product carry over.
Recall initiated
November 10, 2022
Reported by FDA
November 23, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05

by Viatris Inc

Reason
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Recall initiated
October 21, 2022
Reported by FDA
November 23, 2022
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

by ICU Medical Inc

Reason
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Recall initiated
November 9, 2022
Reported by FDA
November 23, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01

by Par Formulations Private Limited

Reason
Failed Impurities/Degradation Specifications
Recall initiated
November 10, 2022
Reported by FDA
November 23, 2022
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.

by ImprimisRx NJ

Reason
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Recall initiated
November 9, 2022
Reported by FDA
November 23, 2022
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA.

by Aadi Bioscience

Reason
Failed Stability Specifications
Recall initiated
October 13, 2022
Reported by FDA
November 23, 2022
Distribution
Within the U.S Market - PA, AL, KY, TN

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Drug Recall Terminated Historical recordClass I

Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton).

by Viatris Inc

Reason
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Recall initiated
October 7, 2022
Reported by FDA
November 16, 2022
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recall initiated
October 7, 2022
Reported by FDA
November 9, 2022
Distribution
AL, LA, MS, and TN

View recall →

Drug Recall Ongoing Historical recordClass II

VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recall initiated
October 7, 2022
Reported by FDA
November 9, 2022
Distribution
AL, LA, MS, and TN

View recall →

Drug Recall Ongoing Historical recordClass II

TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recall initiated
October 7, 2022
Reported by FDA
November 9, 2022
Distribution
AL, LA, MS, and TN

View recall →

Drug Recall Ongoing Historical recordClass II

SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recall initiated
October 7, 2022
Reported by FDA
November 9, 2022
Distribution
AL, LA, MS, and TN

View recall →

Drug Recall Ongoing Historical recordClass II

SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recall initiated
October 7, 2022
Reported by FDA
November 9, 2022
Distribution
AL, LA, MS, and TN

View recall →

Drug Recall Ongoing Historical recordClass II

PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recall initiated
October 7, 2022
Reported by FDA
November 9, 2022
Distribution
AL, LA, MS, and TN

View recall →

Drug Recall Ongoing Historical recordClass II

PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recall initiated
October 7, 2022
Reported by FDA
November 9, 2022
Distribution
AL, LA, MS, and TN

View recall →

Drug Recall Ongoing Historical recordClass II

PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recall initiated
October 7, 2022
Reported by FDA
November 9, 2022
Distribution
AL, LA, MS, and TN

View recall →

Drug Recall Ongoing Historical recordClass II

PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recall initiated
October 7, 2022
Reported by FDA
November 9, 2022
Distribution
AL, LA, MS, and TN

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.