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 3541–3560 of 17,723 recalls

Class IITerminated

Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

Pfizer Inc.

CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

April 22, 2022 · DrugView details →

Class IITerminated

Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

Pfizer Inc.

CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

April 22, 2022 · DrugView details →

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

FDA Drug Recalls

Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64

Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-053-68

Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67

Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-65

TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand Sanitizer Non-Sterile Solution, FDA Approved, 76590-8347-1, 3780 mL, 3.78 Liters (1 Gallon). Torco Race Fuels 2527 W. Dallas Ave. Apache Junction, AZ, 85120

Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704,

Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04

Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA

Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16