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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

Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01

by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Reason: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Recall initiated: August 10, 2017
Reported by FDA: January 3, 2018
Distribution: SSM Health entities in the state of MO only

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Drug Recall Terminated Historical recordClass II

Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fenton, MO --- NDC: 88890-0334-01

by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Reason: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Recall initiated: August 10, 2017
Reported by FDA: January 3, 2018
Distribution: SSM Health entities in the state of MO only

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Drug Recall Terminated Historical recordClass II

Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01

by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Reason: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Recall initiated: August 10, 2017
Reported by FDA: January 3, 2018
Distribution: SSM Health entities in the state of MO only

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Drug Recall Terminated Historical recordClass II

Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88887-6795-01

by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Reason: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Recall initiated: August 10, 2017
Reported by FDA: January 3, 2018
Distribution: SSM Health entities in the state of MO only

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Drug Recall Terminated Historical recordClass II

HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01

by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Reason: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Recall initiated: August 10, 2017
Reported by FDA: January 3, 2018
Distribution: SSM Health entities in the state of MO only

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Drug Recall Terminated Historical recordClass II

Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01

by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Reason: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Recall initiated: August 10, 2017
Reported by FDA: January 3, 2018
Distribution: SSM Health entities in the state of MO only

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Drug Recall Terminated Historical recordClass II

Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-0333-01

by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Reason: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Recall initiated: August 10, 2017
Reported by FDA: January 3, 2018
Distribution: SSM Health entities in the state of MO only

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Drug Recall Terminated Historical recordClass II

Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81

by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Reason: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Recall initiated: August 10, 2017
Reported by FDA: January 3, 2018
Distribution: SSM Health entities in the state of MO only

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Drug Recall Terminated Historical recordClass III

Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577

by Bayer HealthCare Pharmaceuticals, Inc.

Reason: Failed Stability Specifications
Recall initiated: November 10, 2017
Reported by FDA: January 3, 2018
Distribution: Natonwide

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Drug Recall Terminated Historical recordClass II

Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05

by Simple Diagnostics, Inc.

Reason: Lack of Assurance of Sterility and cGMP Deviations
Recall initiated: September 5, 2017
Reported by FDA: January 3, 2018
Distribution: Product was distributed throughout the United States

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Drug Recall Terminated Historical recordClass III

Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01

by Keryx Biopharmaceuticals, Inc.

Reason: Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Recall initiated: December 12, 2017
Reported by FDA: January 3, 2018
Distribution: Distributed nationwide in the USA

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Drug Recall Terminated Historical recordClass III

HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78

by PharMEDium Services, LLC

Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date
Recall initiated: September 26, 2017
Reported by FDA: January 3, 2018
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass III

morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78

by PharMEDium Services, LLC

Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date
Recall initiated: September 26, 2017
Reported by FDA: January 3, 2018
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass III

morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28

by PharMEDium Services, LLC

Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date
Recall initiated: September 26, 2017
Reported by FDA: January 3, 2018
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

All Sterile Products within expiry

by Vital Rx, Inc. dba Atlantic Pharmacy and Compounding

Reason: Lack of Assurance of Sterility .
Recall initiated: August 17, 2017
Reported by FDA: December 27, 2017
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15

by Premier Pharmacy Labs Inc

Reason: Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Recall initiated: August 10, 2017
Reported by FDA: December 27, 2017
Distribution: Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida

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Drug Recall Terminated Historical recordClass II

Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo, Allegan, MI 49010, NDC 70085-151-01

by L. Perrigo Company

Reason: Microbial Contamination of Non-Sterile Products
Recall initiated: November 8, 2017
Reported by FDA: December 27, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249

by Claris Lifesciences Inc

Reason: Superpotent
Recall initiated: November 6, 2017
Reported by FDA: December 27, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass I

NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.

by The Ampt Life, LLC

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
Recall initiated: August 1, 2017
Reported by FDA: December 27, 2017
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28

by Teva Pharmaceuticals USA

Reason: Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Recall initiated: November 20, 2017
Reported by FDA: December 27, 2017
Distribution: Nationwide in the USA and Puerto Rico

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Data last updated: September 24, 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.