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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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Drug Recall Terminated Historical recordClass II

potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6060-1

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

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Drug Recall Terminated Historical recordClass II

Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with low calcium and HEPARIN, IV Bag, Total Volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0430-1

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

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Drug Recall Terminated Historical recordClass II

heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7023-1

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

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Drug Recall Terminated Historical recordClass II

oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6043-1

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

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Drug Recall Terminated Historical recordClass II

oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1

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

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Drug Recall Terminated Historical recordClass II

vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/mL), IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6071-1

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

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Drug Recall Terminated Historical recordClass II

vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1

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

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Drug Recall Terminated Historical recordClass II

phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1

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

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Drug Recall Terminated Historical recordClass II

PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1.

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

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Drug Recall Terminated Historical recordClass II

phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Data last updated: November 2, 2026 ET

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.