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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 4,581–4,600 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 12, 2021
Reported by FDA
January 5, 2022
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 12, 2021
Reported by FDA
January 5, 2022
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 12, 2021
Reported by FDA
January 5, 2022
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass I

Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2

by Gilead Sciences, Inc.

Reason
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Recall initiated
December 3, 2021
Reported by FDA
January 5, 2022
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416

by Aroma Release Technologies Inc

Reason
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Recall initiated
November 30, 2021
Reported by FDA
January 5, 2022
Distribution
Distributed in the states of Texas and New York.

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Drug Recall Terminated Historical recordClass II

Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29

by Teligent Pharma, Inc.

Reason
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Recall initiated
August 23, 2021
Reported by FDA
January 5, 2022
Distribution
Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64

by Teligent Pharma, Inc.

Reason
Superpotent Drug: Minimally superpotent
Recall initiated
November 30, 2021
Reported by FDA
January 5, 2022
Distribution
Distributed to a wholesaler in CO who further distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64

by Teligent Pharma, Inc.

Reason
Superpotent Drug
Recall initiated
November 30, 2021
Reported by FDA
January 5, 2022
Distribution
Distributed to a wholesaler in CO who further distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454

by Teva Pharmaceuticals USA

Reason
Subpotent
Recall initiated
December 16, 2021
Reported by FDA
December 29, 2021
Distribution
nationwide

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Drug Recall Terminated Historical recordClass II

Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08

by Efficient Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
August 24, 2021
Reported by FDA
December 29, 2021
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166

by Efficient Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
August 24, 2021
Reported by FDA
December 29, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06

by Efficient Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
August 24, 2021
Reported by FDA
December 29, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06

by Efficient Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
August 24, 2021
Reported by FDA
December 29, 2021
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40

by The Harvard Drug Group

Reason
Failed Impurities/Degradation Specifications
Recall initiated
August 3, 2021
Reported by FDA
December 29, 2021
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42

by Denver Solutions, LLC DBA Leiters Health

Reason
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Recall initiated
November 29, 2021
Reported by FDA
December 29, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093.

by Medline Industries Inc

Reason
Defective Container: Customer complaints for leaking bottles and dispensing issues.
Recall initiated
November 8, 2021
Reported by FDA
December 29, 2021
Distribution
Nationwide in the USA, Canada, Hong Kong, and Peru

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Drug Recall Terminated Historical recordClass III

Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30

by Torrent Pharma Inc.

Reason
Superpotent; Hydrochlorothiazide
Recall initiated
December 1, 2021
Reported by FDA
December 22, 2021
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409

by Valgene Incorporated dba Cape Drugs

Reason
Lack of Processing Controls
Recall initiated
December 3, 2021
Reported by FDA
December 22, 2021
Distribution
Maryland Only

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409

by Valgene Incorporated dba Cape Drugs

Reason
Lack of Processing Controls
Recall initiated
December 3, 2021
Reported by FDA
December 22, 2021
Distribution
Maryland Only

View recall →

Drug Recall Terminated Historical recordClass II

Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68

by Tolmar, Inc.

Reason
Superpotent Drug
Recall initiated
November 8, 2021
Reported by FDA
December 22, 2021
Distribution
Nationwide within the United States

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.