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FDA Recalls
›Drug Recalls

FDA Drug Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 401–420 of 1,000 recalls

Class IIITerminated

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06

Sandoz Inc

Labeling: Incorrect or missing package insert.

October 17, 2019 · DrugView details →

Class IIITerminated

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.

Sandoz Inc

Labeling: Incorrect or missing package insert.

October 17, 2019 · DrugView details →

Class IIITerminated

Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.

Sandoz Inc

Labeling: Incorrect or missing package insert.

October 17, 2019 · DrugView details →

Class IIITerminated

Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3

Amneal Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.

October 16, 2019 · DrugView details →

Class IIITerminated

Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1

X-Gen Pharmaceuticals Inc.

Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.

October 11, 2019 · DrugView details →

Class IIITerminated

Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.

KVK-Tech, Inc.

Presence of Foreign Substance; Fiber particles.

October 4, 2019 · DrugView details →

Class IIITerminated

Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 59779-534-01. UPC 050428345535

Sato Pharmaceutical Inc.

Subpotent Drug

October 1, 2019 · DrugView details →

Class IIITerminated

Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO PHARMACEUTICAL CO., LTD., 1-5-27 Motoakasaka Minato-KU Tokyo, Japan; SATO PHARMACEUTICAL, INC., 20695 S. Western Ave., Suite 240, Torrance, CA 90501; NDC 49873-404-01.

Sato Pharmaceutical Inc.

Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.

October 1, 2019 · DrugView details →

Class IIITerminated

Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946

Sato Pharmaceutical Inc.

Subpotent Drug

October 1, 2019 · DrugView details →

Class IIITerminated

WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-1407-01, UPC 3 11917-18328 2 ) and b) 18-count boxes (NDC 0363-1407-02, UPC 3 11917-20318 8) Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501,

Sato Pharmaceutical Inc.

Subpotent Drug

October 1, 2019 · DrugView details →

Class IIITerminated

Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603

Sato Pharmaceutical Inc.

Subpotent Drug

October 1, 2019 · DrugView details →

Class IIITerminated

Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01

Arbor Pharmaceuticals Inc.

Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials

September 27, 2019 · DrugView details →

Class IIITerminated

Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10

Amneal Pharmaceuticals, Inc.

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

September 24, 2019 · DrugView details →

Class IIITerminated

Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Company, LLC., Raleigh, NC 27616; NDC 0019-1188-27.

GUERBET LLC

Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.

September 13, 2019 · DrugView details →

Class IIITerminated

Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24

Pfizer Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.

September 12, 2019 · DrugView details →

Class IIITerminated

ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2

Pfizer Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.

September 12, 2019 · DrugView details →

Class IIITerminated

Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35

Mylan Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:OOS for unknown impurity.

September 6, 2019 · DrugView details →

Class IIITerminated

Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 52544-692-30

Teva Pharmaceuticals USA

GMP Deviation: lot not intended for commercial distribution.

September 6, 2019 · DrugView details →

Class IIITerminated

Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH

American Health Packaging

Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.

August 27, 2019 · DrugView details →

Class IIITerminated

minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI Health, LLC 134 Columbus St. Charleston, SC 29403 USA. NDC 71403-102-05.

EPI Health, LLC

Failed Dissolution Specifications:

August 26, 2019 · DrugView details →

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