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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 3,381–3,400 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass I

Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, packaged in Net Wt 6 oz. aluminum spray can, Distributed by: Edgewell Personal Care Brands, LLC, Shelton, CT 06484, UPC 0 79656 04041 8

by Edgewell Personal Care Brands, LLC

Reason
Chemical contamination: presence of benzene
Recall initiated
July 29, 2022
Reported by FDA
September 21, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

by CIPLA

Reason
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Recall initiated
August 22, 2022
Reported by FDA
September 14, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.

by CIPLA

Reason
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Recall initiated
August 22, 2022
Reported by FDA
September 14, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35

by Akorn, Inc.

Reason
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Recall initiated
August 31, 2022
Reported by FDA
September 14, 2022
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31

by Akorn, Inc.

Reason
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Recall initiated
August 31, 2022
Reported by FDA
September 14, 2022
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6980-72

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152. NDC 0904-6844-70

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6741-72

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6740-70

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6820-76

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6738-70

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73.

by Plastikon Healthcare LLC

Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed 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.