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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

fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164

by SCA Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: November 9, 2023
Reported by FDA: April 3, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964

by SCA Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: November 9, 2023
Reported by FDA: April 3, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122

by SCA Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: November 9, 2023
Reported by FDA: April 3, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164

by SCA Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: November 9, 2023
Reported by FDA: April 3, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132

by SCA Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: November 9, 2023
Reported by FDA: April 3, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230

by SCA Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: November 9, 2023
Reported by FDA: April 3, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940

by SCA Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: November 9, 2023
Reported by FDA: April 3, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135

by SCA Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: November 9, 2023
Reported by FDA: April 3, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.

by Super Chill Products

Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Recall initiated: February 5, 2024
Reported by FDA: March 27, 2024
Distribution: Nationwide in the U.S.

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Drug Recall Ongoing Historical recordClass II

Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01

by Hikma Pharmaceuticals USA Inc.

Reason: The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Recall initiated: March 12, 2024
Reported by FDA: March 27, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11

by Eugia US LLC

Reason: Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Recall initiated: February 20, 2024
Reported by FDA: March 27, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

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

by Eugia US LLC

Reason: Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Recall initiated: February 20, 2024
Reported by FDA: March 27, 2024
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

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

by Novitium Pharma LLC

Reason: Cross Contamination with Other Products:(mycophenolate mofetil).
Recall initiated: March 4, 2024
Reported by FDA: March 27, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

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.

by Micro Labs Limited

Reason: Failed Stability Specifications: Out of specification for blend uniformity.
Recall initiated: February 9, 2024
Reported by FDA: March 20, 2024
Distribution: Puerto Rico, TN, RI

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Drug Recall Ongoing Historical recordClass II

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

by Global Corporation

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.
Recall initiated: February 16, 2024
Reported by FDA: March 20, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

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

by Global Corporation

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.
Recall initiated: February 16, 2024
Reported by FDA: March 20, 2024
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

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.

by Eugia US LLC

Reason: Failed Stability Specification: Water determination was found not complying with specification.
Recall initiated: February 22, 2024
Reported by FDA: March 20, 2024
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

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

by Optikem International, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: February 29, 2024
Reported by FDA: March 20, 2024
Distribution: Product distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

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.

by Optikem International, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: February 29, 2024
Reported by FDA: March 20, 2024
Distribution: Product distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

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.

by Optikem International, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: February 29, 2024
Reported by FDA: March 20, 2024
Distribution: Product distributed Nationwide in the USA

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Data last updated: November 1, 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.