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 10561–10580 of 17,793 recalls

Class IITerminated

Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.

Isomeric Pharmacy Solution, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

April 6, 2017 · DrugView details →
Class IITerminated

Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-605-52

PharMedium Services, Llc

Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.

April 6, 2017 · Drug
View details →
Class IITerminated

Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3.

Isomeric Pharmacy Solution, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

April 6, 2017 · DrugView details →
Class IIITerminated

Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla Limited Kurkumbh, Maharashtra, India, Manufactured for West-Ward, Pharmaceuticals, Corp., Eatontown, NJ -- NDC 0054-0338-19

West-Ward Columbus, Inc.

Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.

April 4, 2017 · DrugView details →
Class IITerminated

ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0869

Medisca, Inc.

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

April 3, 2017 · DrugView details →
Class IITerminated

Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ

Cell Distributors

Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.

April 3, 2017 · DrugView details →
Class IITerminated

ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732

Medisca, Inc.

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

April 3, 2017 · DrugView details →
Class IITerminated

ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261

Medisca, Inc.

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

April 3, 2017 · DrugView details →
Class IITerminated

ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891

Medisca, Inc.

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

April 3, 2017 · DrugView details →
Class IITerminated

Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194

Bayer HealthCare Pharmaceuticals, Inc.

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

March 30, 2017 · DrugView details →
Class IITerminated

Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500041085

Bayer HealthCare Pharmaceuticals, Inc.

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

March 30, 2017 · DrugView details →
Class IITerminated

Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048

Bayer HealthCare Pharmaceuticals, Inc.

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

March 30, 2017 · DrugView details →
Class IITerminated

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532

Taro Pharmaceuticals U.S.A., Inc.

Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability

March 28, 2017 · DrugView details →
Class IIITerminated

PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87

Teva Pharmaceuticals USA

Failed Stability Specifications

March 28, 2017 · DrugView details →
Class ITerminated

LaBri's Body Health Atomic, 60 capsules

Envy Me

Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.

March 28, 2017 · DrugView details →
Class IITerminated

hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, Stabilizers/Excipients, Not For Medical Use, Must Be Refrigerated, Distributed by HCG Body Shaper, St. Peters, MO

Gary Wood

Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug

March 28, 2017 · DrugView details →
Class IITerminated

Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06

Qinhuangdao Zizhu Pharmaceutical, Co.

cGMP Deviations; lack of quality assurance.

March 24, 2017 · DrugView details →
Class IITerminated

Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06)

Qinhuangdao Zizhu Pharmaceutical, Co.

cGMP Deviations; lack of quality assurance.

March 24, 2017 · DrugView details →
Class IITerminated

Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06)

Qinhuangdao Zizhu Pharmaceutical, Co.

cGMP Deviations; lack of quality assurance.

March 24, 2017 · DrugView details →
Class IITerminated

Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)

Qinhuangdao Zizhu Pharmaceutical, Co.

cGMP Deviations; lack of quality assurance.

March 24, 2017 · DrugView details →
← PreviousPage 529 of 890Next →