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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 15,381–15,400 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass III

ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04

by Hill Dermaceuticals, Inc.

Reason
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Recall initiated
January 31, 2014
Reported by FDA
April 2, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04

by Hill Dermaceuticals, Inc.

Reason
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Recall initiated
January 31, 2014
Reported by FDA
April 2, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04

by Hill Dermaceuticals, Inc.

Reason
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Recall initiated
January 31, 2014
Reported by FDA
April 2, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04

by Hill Dermaceuticals, Inc.

Reason
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Recall initiated
January 31, 2014
Reported by FDA
April 2, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20

by Hill Dermaceuticals, Inc.

Reason
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Recall initiated
January 31, 2014
Reported by FDA
April 2, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5555-3.

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Recall initiated
February 13, 2014
Reported by FDA
March 26, 2014
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3.

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Recall initiated
February 13, 2014
Reported by FDA
March 26, 2014
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass I

Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)

by Fabscout Entertainment, Inc

Reason
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
Recall initiated
June 27, 2013
Reported by FDA
March 26, 2014
Distribution
Nationwide and France

View recall →

Drug Recall Terminated Historical recordClass I

Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)

by Fabscout Entertainment, Inc

Reason
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
Recall initiated
June 27, 2013
Reported by FDA
March 26, 2014
Distribution
Nationwide and France

View recall →

Drug Recall Terminated Historical recordClass II

Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01

by Paddock Laboratories, LLC

Reason
Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml.
Recall initiated
March 11, 2014
Reported by FDA
March 26, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10

by Mckesson Packaging Services

Reason
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Recall initiated
March 3, 2014
Reported by FDA
March 26, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43

by Pfizer Us Pharmaceutical Group

Reason
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Recall initiated
February 26, 2014
Reported by FDA
March 26, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001

by Traxx International Corp

Reason
Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.
Recall initiated
January 14, 2014
Reported by FDA
March 26, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831***

by RX South LLC DBA RX3 Pharmacy

Reason
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Recall initiated
January 28, 2014
Reported by FDA
March 26, 2014
Distribution
Product was distributed in Virginia and Maryland.

View recall →

Drug Recall Terminated Historical recordClass I

0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Recall initiated
November 21, 2013
Reported by FDA
March 26, 2014
Distribution
Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.

View recall →

Drug Recall Terminated Historical recordClass I

5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.

by Baxter Healthcare Corp.

Reason
Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Recall initiated
November 21, 2013
Reported by FDA
March 26, 2014
Distribution
Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.

View recall →

Drug Recall Terminated Historical recordClass I

Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.

by Hospira Inc.

Reason
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Recall initiated
October 18, 2013
Reported by FDA
March 26, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Recall initiated
November 18, 2013
Reported by FDA
March 26, 2014
Distribution
US Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Recall initiated
November 18, 2013
Reported by FDA
March 26, 2014
Distribution
US Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Recall initiated
November 18, 2013
Reported by FDA
March 26, 2014
Distribution
US 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.