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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 6,761–6,780 of 17,964 drug recalls

Drug Recall Ongoing Historical recordClass II

Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87.

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 22, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product number 3248-01, NDC 10106-3248-1; b) 2.5KG glass bottles, product number 3248-05, NDC 10106-3248-2; c) 12KG pails, product number 3248-07, NDC 10106-3248-3; d) 1KT bottles and drums, product number 3248-X2; e) 1KT bottles and drums, product number 3248-X3; f) 12KG pails, product number 7390-19; Avantor Performance Materials, LLC, 100 Matsonford, Road, Suite 200, Radnor, PA 19087.

by Avantor Performance Materials Inc

Reason
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Recall initiated
October 30, 2019
Reported by FDA
December 4, 2019
Distribution
Nationwide in the USA, Canada, India, and Singapore

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Drug Recall Terminated Historical recordClass II

Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.

by AuroMedics Pharma LLC

Reason
Presence of Foreign Substance: Foreign material found inside the vial.
Recall initiated
November 11, 2019
Reported by FDA
December 4, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01

by Preferred Pharmaceuticals, Inc

Reason
Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Recall initiated
November 21, 2019
Reported by FDA
December 4, 2019
Distribution
CA, FL, IL

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Drug Recall Ongoing Historical recordClass II

Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05

by AuroMedics Pharma LLC

Reason
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recall initiated
November 6, 2019
Reported by FDA
December 4, 2019
Distribution
nationwide

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Drug Recall Ongoing Historical recordClass II

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74

by AuroMedics Pharma LLC

Reason
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recall initiated
November 6, 2019
Reported by FDA
December 4, 2019
Distribution
nationwide

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Drug Recall Ongoing Historical recordClass II

Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30

by AuroMedics Pharma LLC

Reason
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recall initiated
November 6, 2019
Reported by FDA
December 4, 2019
Distribution
nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60

by AuroMedics Pharma LLC

Reason
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recall initiated
November 6, 2019
Reported by FDA
December 4, 2019
Distribution
nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79

by AuroMedics Pharma LLC

Reason
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recall initiated
November 6, 2019
Reported by FDA
December 4, 2019
Distribution
nationwide

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Drug Recall Terminated Historical recordClass II

AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30

by AVKARE Inc.

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated
November 14, 2019
Reported by FDA
December 4, 2019
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60

by AVKARE Inc.

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated
November 14, 2019
Reported by FDA
December 4, 2019
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy

by New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
October 1, 2019
Reported by FDA
December 4, 2019
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18

by AuroMedics Pharma LLC

Reason
Crystallization: Presence of visible particulate matter.
Recall initiated
November 11, 2019
Reported by FDA
December 4, 2019
Distribution
Distributed Nationwide in the US

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Drug Recall Terminated Historical recordClass III

Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09

by AuroMedics Pharma LLC

Reason
Crystallization: Presence of visible particulate matter.
Recall initiated
November 11, 2019
Reported by FDA
December 4, 2019
Distribution
Distributed Nationwide in the US

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Drug Recall Terminated Historical recordClass III

Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03

by AuroMedics Pharma LLC

Reason
Crystallization: Presence of visible particulate matter.
Recall initiated
November 11, 2019
Reported by FDA
December 4, 2019
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

by Washington Homeopathic Products, Inc.

Reason
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Recall initiated
November 8, 2019
Reported by FDA
November 27, 2019
Distribution
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia

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Drug Recall Completed Historical recordClass II

OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-505-01

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

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Drug Recall Completed Historical recordClass II

Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC 59390-181-13

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

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.