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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 2,381–2,400 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated
July 14, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Completed Historical recordClass II

Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For Inhalation or Injection, Must be Diluted, Manufactured by: The Ritedose Corporation Columbia, SC 29203 for Ritedose Pharmaceuticals, LLC Columbia, SC 29203, NDC 76204-025-96.

by The Ritedose Corporation

Reason
CGMP deviation: product released prior to supplier approval.
Recall initiated
July 21, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40

by SCA Pharmaceuticals

Reason
cGMP deviations: due to shipment of rejected units.
Recall initiated
July 20, 2023
Reported by FDA
August 2, 2023
Distribution
KY and NJ

View recall →

Drug Recall Ongoing Historical recordClass II

Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213

by New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
July 13, 2023
Reported by FDA
August 2, 2023
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807

by Kramer Laboratories, Inc.

Reason
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Recall initiated
June 23, 2023
Reported by FDA
August 2, 2023
Distribution
nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807

by Kramer Laboratories, Inc.

Reason
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Recall initiated
June 23, 2023
Reported by FDA
August 2, 2023
Distribution
nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

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

by ALEMBIC PHARMACEUTICALS, INC.

Reason
Defective Delivery System
Recall initiated
June 22, 2023
Reported by FDA
August 2, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Presence of Foreign Substance: Metal embedded in a tablet.
Recall initiated
July 13, 2023
Reported by FDA
August 2, 2023
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.

by Sagent Pharmaceuticals

Reason
Lack of Assurance of Sterility
Recall initiated
July 11, 2023
Reported by FDA
August 2, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.

by Sagent Pharmaceuticals

Reason
Lack of Assurance of Sterility
Recall initiated
July 11, 2023
Reported by FDA
August 2, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.

by Sagent Pharmaceuticals

Reason
Lack of Assurance of Sterility
Recall initiated
July 11, 2023
Reported by FDA
August 2, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.

by Glenmark Therapeutics, Inc.

Reason
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Recall initiated
May 1, 2023
Reported by FDA
July 26, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 7, 2023
Reported by FDA
July 26, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 7, 2023
Reported by FDA
July 26, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 7, 2023
Reported by FDA
July 26, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 7, 2023
Reported by FDA
July 26, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 7, 2023
Reported by FDA
July 26, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;

by New England Life Care, Inc. dba Advanced Compounding Solutions

Reason
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Recall initiated
July 10, 2023
Reported by FDA
July 26, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05

by New England Life Care, Inc. dba Advanced Compounding Solutions

Reason
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Recall initiated
July 10, 2023
Reported by FDA
July 26, 2023
Distribution
Nationwide in the USA

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.