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Browse Drug Recalls

27 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 27 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 27 FDA drug recalls.

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DateProductReasonClassFirm
Nov 20, 2023 Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured ... Failed Dissolution Specifications Class III Siegfried Barbera, SL
Sep 8, 2023 SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL b... Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. Class I Novartis Pharmaceuticals Corp.
May 11, 2019 Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by:... Cross Contamination with Other Products: product is being recalled due to possible cross-contamin... Class I Novartis Pharmaceuticals Corp.
Mar 22, 2017 Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles,... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corp.
Mar 22, 2017 Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corp.
Jul 28, 2015 Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsule... Failed Dissolution Specifications: Product is being recalled due to out of specification (above s... Class III Novartis Pharmaceuticals Corp.
May 22, 2015 Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... Failed Stability Specification: out of specification result obtained for the Particle Size Distri... Class III Novartis Pharmaceuticals Corp.
May 22, 2015 Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... Failed Stability Specification: out of specification result obtained for the Particle Size Distri... Class III Novartis Pharmaceuticals Corp.
Jul 30, 2014 Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, M... Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making... Class III Novartis Pharmaceuticals Corp.
May 28, 2014 Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule... Failed Stability Specification; out of specification result for particle size distribution during... Class III Novartis Pharmaceuticals Corp.
Mar 3, 2014 Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only... Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the P... Class III Novartis Pharmaceuticals Corp.
Mar 3, 2014 Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only... Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the P... Class III Novartis Pharmaceuticals Corp.
Aug 8, 2013 Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-N... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bo... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physicia... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 ... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 table... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physicia... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx onl... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx on... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per ... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bo... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per b... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-N... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.