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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 13,521–13,540 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01

by Mutual Pharmaceutical Company, Inc.

Reason
Chemical Contamination; benzophenone leached from the product label varnish
Recall initiated
July 16, 2015
Reported by FDA
September 16, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01

by Mutual Pharmaceutical Company, Inc.

Reason
Chemical Contamination; benzophenone leached from the product label varnish
Recall initiated
July 16, 2015
Reported by FDA
September 16, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36 drop bags (UPC: 050428 476581), Over the Counter. Distributed by: CVS Pharmacy, Inc., One CVS Drive Woonsocket, RI 02895.

by Bestco, Inc.

Reason
Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.
Recall initiated
July 2, 2015
Reported by FDA
September 16, 2015
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass III

ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05

by Oasis Medical, Inc.

Reason
Falied pH specification
Recall initiated
August 31, 2015
Reported by FDA
September 16, 2015
Distribution
FL

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Drug Recall Terminated Historical recordClass II

DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/urethane sponge and 2-count Cotton-tipped swabs per pouch, packaged in 20 pouches per case (NDC 17518-0011-08, UPC (01) 0 03 17518 01108 5) and b) 0.2 fl oz, 6 mL Single Use Applicator w/urethane sponge per pouch, packaged in 50 pouches per case (NDC 17518-0011-07, UPC (01) 0 03 17518 01107 8), OTC, Made in U.S.A. by 3M Health Care, 2510 Conway Ave., St. Paul, MN 55144.

by 3M Company - Health Care Business

Reason
Chemical contamination: Product may be contaminated with a toxic compound.
Recall initiated
August 6, 2015
Reported by FDA
September 16, 2015
Distribution
Nationwide, Puerto Rico, and to foreign distribution centers in Dominican Repulbic, Malaysia, Mexico, Panama, Peru, and United Arab Emirates.

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Drug Recall Terminated Historical recordClass III

Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70

by Silarx Pharmaceutical, Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
Recall initiated
August 21, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recall initiated
April 23, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recall initiated
April 23, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recall initiated
April 23, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recall initiated
April 23, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recall initiated
April 23, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recall initiated
April 23, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recall initiated
April 23, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recall initiated
April 23, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recall initiated
April 23, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811

by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Reason
Failed Dissolution Specifications
Recall initiated
July 29, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28

by Qualitest Pharmaceuticals

Reason
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Recall initiated
July 20, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide and PR

View recall →

Drug Recall Terminated Historical recordClass II

Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA

by South Coast Specialty Compounding, Inc.

Reason
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recall initiated
April 23, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA

by South Coast Specialty Compounding, Inc.

Reason
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recall initiated
April 23, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Recall initiated
April 23, 2015
Reported by FDA
September 9, 2015
Distribution
Nationwide.

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.