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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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Drug Recall Terminated Historical recordClass II

Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9485-07

by Novartis Pharmaceuticals Corp.

Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recall initiated: August 8, 2013
Reported by FDA: December 18, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9407-01

by Novartis Pharmaceuticals Corp.

Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recall initiated: August 8, 2013
Reported by FDA: December 18, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9354-07

by Novartis Pharmaceuticals Corp.

Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recall initiated: August 8, 2013
Reported by FDA: December 18, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9491-07

by Novartis Pharmaceuticals Corp.

Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recall initiated: August 8, 2013
Reported by FDA: December 18, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9489-07

by Novartis Pharmaceuticals Corp.

Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recall initiated: August 8, 2013
Reported by FDA: December 18, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9560-89

by Novartis Pharmaceuticals Corp.

Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recall initiated: August 8, 2013
Reported by FDA: December 18, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9559-89

by Novartis Pharmaceuticals Corp.

Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recall initiated: August 8, 2013
Reported by FDA: December 18, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9563-89

by Novartis Pharmaceuticals Corp.

Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recall initiated: August 8, 2013
Reported by FDA: December 18, 2013
Distribution: Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9490-07

by Novartis Pharmaceuticals Corp.

Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recall initiated: August 8, 2013
Reported by FDA: December 18, 2013
Distribution: Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9488-07

by Novartis Pharmaceuticals Corp.

Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recall initiated: August 8, 2013
Reported by FDA: December 18, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9360-07

by Novartis Pharmaceuticals Corp.

Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recall initiated: August 8, 2013
Reported by FDA: December 18, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9359-07

by Novartis Pharmaceuticals Corp.

Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recall initiated: August 8, 2013
Reported by FDA: December 18, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula, 4fFl.oz Tube, UPC code: 634084490091 (US) UPC Code: 634084490114 (Canada)

by W.S. Badger Company Inc.

Reason: Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
Recall initiated: September 24, 2013
Reported by FDA: December 11, 2013
Distribution: Nationwide and Canada, Greece, Singapore, Thailand, Norway, American Samoa.

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Drug Recall Terminated Historical recordClass II

Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01

by American Health Packaging

Reason: Subpotent
Recall initiated: August 2, 2013
Reported by FDA: December 11, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Trypan Blue 0.15% 1ml , Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Recall initiated: May 28, 2013
Reported by FDA: December 11, 2013
Distribution: nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV

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Drug Recall Terminated Historical recordClass II

Tri-Mix SS Pap 30mg, Phen 1mg, PGE1 10mcg 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Recall initiated: May 28, 2013
Reported by FDA: December 11, 2013
Distribution: nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV

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Drug Recall Terminated Historical recordClass II

Triamcinolone Acetonide 40mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Recall initiated: May 28, 2013
Reported by FDA: December 11, 2013
Distribution: nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV

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Drug Recall Terminated Historical recordClass II

Triamcinolone 40mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Recall initiated: May 28, 2013
Reported by FDA: December 11, 2013
Distribution: nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV

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Drug Recall Terminated Historical recordClass II

Triamcinolone 40mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Recall initiated: May 28, 2013
Reported by FDA: December 11, 2013
Distribution: nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV

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Drug Recall Terminated Historical recordClass II

Triamcinolone PF 40mg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Recall initiated: May 28, 2013
Reported by FDA: December 11, 2013
Distribution: nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV

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Data last updated: October 2, 2026 ET

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.