Civic Data
FDA RecallsUSDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

USDA Recalls

  • All USDA recalls
  • Poultry recalls
  • Meat recalls
  • Egg recalls

About

  • About us
  • FDA guides
  • USDA guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API
  • USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 15061–15080 of 17,832 recalls

Class IITerminated

Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1.

Terra-Medica Inc.

Penicillin Cross Contamination

March 3, 2014 · DrugView details →
Class IITerminated

Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2305-1.

Terra-Medica Inc.

Penicillin Cross Contamination

March 3, 2014 · DrugView details →
Class IITerminated

Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1.

Terra-Medica Inc.

Penicillin Cross Contamination

March 3, 2014 · DrugView details →
Class IITerminated

Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-2.

Terra-Medica Inc.

Penicillin Cross Contamination

March 3, 2014 · DrugView details →
Class IIITerminated

Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901 Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0441-05

Novartis Pharmaceuticals Corp.

Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t

March 3, 2014 · DrugView details →
Class IITerminated

Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1102-1.

Terra-Medica Inc.

Penicillin Cross Contamination

March 3, 2014 · DrugView details →
Class IITerminated

Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1101-1.

Terra-Medica Inc.

Penicillin Cross Contamination

March 3, 2014 · DrugView details →
Class IITerminated

Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1103-1.

Terra-Medica Inc.

Penicillin Cross Contamination

March 3, 2014 · DrugView details →
Class IITerminated

Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1106-1.

Terra-Medica Inc.

Penicillin Cross Contamination

March 3, 2014 · DrugView details →
Class IITerminated

Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2302-1.

Terra-Medica Inc.

Penicillin Cross Contamination

March 3, 2014 · DrugView details →
Class IIITerminated

Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43

Pfizer Us Pharmaceutical Group

Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.

February 26, 2014 · DrugView details →
Class IITerminated

All sterile drugs compounded between 2/21/14 and 2/24/14.

New England Home Therapies, Inc

Lack of Assurance of Sterility: All compounded products.

February 26, 2014 · DrugView details →
Class IIITerminated

Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

February 20, 2014 · DrugView details →
Class IIITerminated

Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

February 20, 2014 · DrugView details →
Class IIITerminated

Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

February 20, 2014 · DrugView details →
Class IIITerminated

Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

February 20, 2014 · DrugView details →
Class IIITerminated

Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

February 20, 2014 · DrugView details →
Class IIITerminated

Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

February 20, 2014 · DrugView details →
Class IIITerminated

Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

February 20, 2014 · DrugView details →
Class IIITerminated

Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

February 20, 2014 · DrugView details →
← PreviousPage 754 of 892Next →