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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 8,801–8,820 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Cyclosporin liquid 0.2%, Rx, plastic dropper bottle

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

Cyclosporin liquid 0.5%, Rx, plastic dropper bottle

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

Cyclosporin liquid 1%, Rx, plastic dropper bottle

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

Vitamin B12 liquid 1000mcg/ml, RX, glass vial

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

Testosteron Cypionate liquid 200mg/ml, RX, glass vial

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

Methocarbamol liquid 100mg/ml, RX, glass vial

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

Lidocaine gel 2%, RX, plastic dropper

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

HCG liquid, 1000u/ml, RX, glass vial, various

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

Glutathione liquid, 100mg/ml

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

View recall →

Drug Recall Terminated Historical recordClass II

Epinephrine liquid 1:1000, RX, glass vial

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

View recall →

Drug Recall Terminated Historical recordClass II

Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11.

by LUPIN SOMERSET

Reason
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Recall initiated
December 21, 2018
Reported by FDA
January 9, 2019
Distribution
Nationwide in the USA and Puerto Rico.

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Drug Recall Terminated Historical recordClass I

Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.

by Advanced Pharma Inc.

Reason
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Recall initiated
November 29, 2018
Reported by FDA
January 2, 2019
Distribution
Heath care facilities in NM, TX, and OH

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Drug Recall Terminated Historical recordClass III

Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14

by Amerigen Pharmaceuticals Inc.

Reason
Failed Dissolution Specifications
Recall initiated
December 20, 2018
Reported by FDA
January 2, 2019
Distribution
Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.

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Drug Recall Terminated Historical recordClass III

Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ

by Amerigen Pharmaceuticals Inc.

Reason
Failed Dissolution Specifications
Recall initiated
December 20, 2018
Reported by FDA
January 2, 2019
Distribution
Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.

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Drug Recall Terminated Historical recordClass III

Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack)

by Sun Pharmaceutical Industries, Inc.

Reason
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Recall initiated
December 7, 2018
Reported by FDA
December 26, 2018
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02

by Cipla Limited

Reason
Failed Dissolution Specifications.
Recall initiated
December 14, 2018
Reported by FDA
December 26, 2018
Distribution
Nationwide within the United States

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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.