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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 6,121–6,140 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03

by Lupin Pharmaceuticals Inc.

Reason
Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
Recall initiated
April 20, 2020
Reported by FDA
April 29, 2020
Distribution
Product was distributed Nationwide in the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3

by Noven Therapeutics, LLC

Reason
Defective Delivery System: Out of specification for mechanical peel and shear.
Recall initiated
March 31, 2020
Reported by FDA
April 29, 2020
Distribution
Distributed Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3

by Noven Therapeutics, LLC

Reason
Defective Delivery System: Out of specification for mechanical peel and shear.
Recall initiated
March 31, 2020
Reported by FDA
April 29, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3

by Noven Therapeutics, LLC

Reason
Defective Delivery System: Out of specification for mechanical peel and shear.
Recall initiated
March 31, 2020
Reported by FDA
April 29, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433

by H J Harkins Company Inc dba Pharma Pac

Reason
cGMP Deviations
Recall initiated
April 15, 2020
Reported by FDA
April 22, 2020
Distribution
Product was distributed in CA and AZ.

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Drug Recall Terminated Historical recordClass II

Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100

by B & B Pharmaceuticals, Inc.

Reason
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Recall initiated
April 14, 2020
Reported by FDA
April 22, 2020
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144

by Filltech USA, LLC

Reason
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Recall initiated
March 19, 2020
Reported by FDA
April 22, 2020
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698

by Filltech USA, LLC

Reason
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Recall initiated
March 19, 2020
Reported by FDA
April 22, 2020
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recall initiated
March 18, 2020
Reported by FDA
April 22, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recall initiated
March 18, 2020
Reported by FDA
April 22, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recall initiated
March 18, 2020
Reported by FDA
April 22, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recall initiated
March 18, 2020
Reported by FDA
April 22, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recall initiated
March 18, 2020
Reported by FDA
April 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recall initiated
March 18, 2020
Reported by FDA
April 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recall initiated
March 18, 2020
Reported by FDA
April 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recall initiated
March 18, 2020
Reported by FDA
April 22, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Levothyroxin (T4)/Liothyronine (T3) SR 130 mg/175 mg capsule 21 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

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Drug Recall Terminated Historical recordClass II

Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

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Drug Recall Terminated Historical recordClass II

Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository (Pink) 48 suppositories, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

View recall →

Drug Recall Terminated Historical recordClass II

Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

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.