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  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 17461–17480 of 17,860 recalls

Class IITerminated

Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.SA ***

Mylan Pharmaceuticals Inc.

Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.

August 7, 2012 · DrugView details →
Class IITerminated

Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24

Hospira Inc.

Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.

August 3, 2012 · DrugView details →
Class IITerminated

Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30

Dr. Reddy's Laboratories, Inc.

Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.

August 1, 2012 · DrugView details →
Class IITerminated

Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30

Dr. Reddy's Laboratories, Inc.

Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.

August 1, 2012 · DrugView details →
Class IITerminated

Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-343-30

Dr. Reddy's Laboratories, Inc.

Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.

August 1, 2012 · DrugView details →
Class ITerminated

Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit; Investigation Use only, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990.

Genentech Inc

Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.

July 30, 2012 · DrugView details →
Class IIITerminated

Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134

Mallinckrodt Inc

Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)

July 30, 2012 · DrugView details →
Class IIITerminated

Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2.

Natural Essentials Inc

Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.

July 27, 2012 · DrugView details →
Class IITerminated

Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541

Capco Custom Packaging Inc

Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.

July 27, 2012 · DrugView details →
Class IITerminated

Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05

Mylan Pharmaceuticals Inc.

Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.

July 27, 2012 · DrugView details →
Class IITerminated

Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20

GlaxoSmithKline Inc

Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.

July 26, 2012 · DrugView details →
Class IITerminated

Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

Lloyd Inc. of Iowa

Subpotent; 9-month stability interval

July 25, 2012 · DrugView details →
Class IIITerminated

Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, Pkg by: American Health Packaging, Col. OH 43217, NDC 68084-343-21, blister barcode 6808434311

American Health Packaging

Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".

July 25, 2012 · DrugView details →
Class IITerminated

Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

Lloyd Inc. of Iowa

Subpotent; 9-month stability interval

July 25, 2012 · DrugView details →
Class IITerminated

Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA

Lloyd Inc. of Iowa

Subpotent; 9-month stability interval

July 25, 2012 · DrugView details →
Class IITerminated

Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

Lloyd Inc. of Iowa

Subpotent; 9-month stability interval

July 25, 2012 · DrugView details →
Class IITerminated

OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102-01, UPC 3 43825 10201 7.

Cadence Pharmaceuticals

Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.

July 24, 2012 · DrugView details →
Class IIITerminated

Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.

Stat Rx USA

Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.

July 23, 2012 · DrugView details →
Class IITerminated

CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568, the tray also contains other components not listed in this product description.

Custom Medical Specialties, Inc.

Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.

July 23, 2012 · DrugView details →
Class IITerminated

CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description.

Custom Medical Specialties, Inc.

Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.

July 23, 2012 · DrugView details →
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