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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 3,301–3,320 of 18,075 drug recalls

Drug Recall Ongoing Historical recordClass II

SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th Beverages, LLC, Lincoln, NE 68522 and Bottled by South Tenth Development, LLC, Lincoln, NE 68522.

by Southwest Iowa Renewable Energy LLC

Reason
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Recall initiated
October 6, 2022
Reported by FDA
January 25, 2023
Distribution
IA, NE

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Drug Recall Terminated Historical recordClass II

Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-586-01 (Individual Dose NDC: 60687-586-11)

by Amerisource Health Services LLC

Reason
Failed Impurities/Degradations Specifications
Recall initiated
December 20, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.

by Fisher Scientific Co., LLC

Reason
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Recall initiated
January 17, 2023
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.

by Fisher Scientific Co., LLC

Reason
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Recall initiated
January 17, 2023
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08

by MACLEODS PHARMA USA, INC

Reason
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Recall initiated
January 5, 2023
Reported by FDA
January 25, 2023
Distribution
Nationwide within United States and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10

by Lannett Company Inc.

Reason
Failed Impurity/Degradation Specifications
Recall initiated
November 9, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass III

Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10

by Lannett Company Inc.

Reason
Failed Impurity/Degradation Specifications
Recall initiated
November 9, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054

by Ascend Laboratories, LLC

Reason
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Recall initiated
December 28, 2022
Reported by FDA
January 25, 2023
Distribution
Customers in 19 states: CA, FL, GA, IL, KY, LA, MI, MN, MS, NC, NJ, NY, OH, PA, RI, TN, TX, WA, WI; Puerto Rico

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Drug Recall Ongoing Historical recordClass II

Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05

by Akorn, Inc.

Reason
CGMP Deviations:
Recall initiated
October 13, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10

by Akorn, Inc.

Reason
CGMP Deviations:
Recall initiated
October 13, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.

by Akorn, Inc.

Reason
CGMP Deviations:
Recall initiated
October 13, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35

by Akorn, Inc.

Reason
CGMP Deviations:
Recall initiated
October 13, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15

by Akorn, Inc.

Reason
CGMP Deviations:
Recall initiated
October 13, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12

by Akorn, Inc.

Reason
CGMP Deviations:
Recall initiated
October 13, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12

by Akorn, Inc.

Reason
CGMP Deviations:
Recall initiated
October 13, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05

by Akorn, Inc.

Reason
CGMP Deviations:
Recall initiated
October 13, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05

by Akorn, Inc.

Reason
CGMP Deviations:
Recall initiated
October 13, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12

by Akorn, Inc.

Reason
CGMP Deviations:
Recall initiated
October 13, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05

by Akorn, Inc.

Reason
CGMP Deviations:
Recall initiated
October 13, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05

by Akorn, Inc.

Reason
CGMP Deviations:
Recall initiated
October 13, 2022
Reported by FDA
January 25, 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.

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