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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 11,621–11,640 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-909-32; Blister NDC 68084-909-33

by Amerisource Health Services

Reason
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Recall initiated
August 24, 2016
Reported by FDA
September 14, 2016
Distribution
Product was distributed in the following states: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-832-25; Blister NDC 68084-832-95

by Amerisource Health Services

Reason
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Recall initiated
August 24, 2016
Reported by FDA
September 14, 2016
Distribution
Product was distributed in the following states: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-898-32; Blister NDC 68084-898-33

by Amerisource Health Services

Reason
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Recall initiated
August 24, 2016
Reported by FDA
September 14, 2016
Distribution
Product was distributed in the following states: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-815-25; Blister NDC 68084-815-95

by Amerisource Health Services

Reason
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Recall initiated
August 24, 2016
Reported by FDA
September 14, 2016
Distribution
Product was distributed in the following states: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 60687-154-25; Blister NDC 60687-154-95

by Amerisource Health Services

Reason
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Recall initiated
August 24, 2016
Reported by FDA
September 14, 2016
Distribution
Product was distributed in the following states: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-943-25; Blister NDC 68084-943-95

by Amerisource Health Services

Reason
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Recall initiated
August 24, 2016
Reported by FDA
September 14, 2016
Distribution
Product was distributed in the following states: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 60687-133-25; Blister NDC 60687-133-95

by Amerisource Health Services

Reason
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Recall initiated
August 24, 2016
Reported by FDA
September 14, 2016
Distribution
Product was distributed in the following states: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-936-25; Blister NDC 68084-936-95

by Amerisource Health Services

Reason
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Recall initiated
August 24, 2016
Reported by FDA
September 14, 2016
Distribution
Product was distributed in the following states: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-874-25; Blister NDC 68084-874-95

by Amerisource Health Services

Reason
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Recall initiated
August 24, 2016
Reported by FDA
September 14, 2016
Distribution
Product was distributed in the following states: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,

by Isomeric Pharmacy Solution, LLC

Reason
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
Recall initiated
June 29, 2016
Reported by FDA
September 14, 2016
Distribution
Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.

View recall →

Drug Recall Terminated Historical recordClass III

Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06

by Stason Pharmaceuticals, Inc.

Reason
Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
Recall initiated
August 23, 2016
Reported by FDA
September 14, 2016
Distribution
North Carolina

View recall →

Drug Recall Terminated Historical recordClass III

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48241-1, Shade 06 (D-G)

by Clinique International

Reason
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Recall initiated
May 17, 2016
Reported by FDA
September 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48240-4, Shade 05 (D-G)

by Clinique International

Reason
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Recall initiated
May 17, 2016
Reported by FDA
September 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47479-9, Shade 04 (M-N)

by Clinique International

Reason
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Recall initiated
May 17, 2016
Reported by FDA
September 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N)

by Clinique International

Reason
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Recall initiated
May 17, 2016
Reported by FDA
September 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47477-5, Shade 02 (VF-N)

by Clinique International

Reason
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Recall initiated
May 17, 2016
Reported by FDA
September 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N)

by Clinique International

Reason
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Recall initiated
May 17, 2016
Reported by FDA
September 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61

by Actavis Inc

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Recall initiated
August 2, 2016
Reported by FDA
August 31, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82

by Actavis Inc

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Recall initiated
August 2, 2016
Reported by FDA
August 31, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76

by Teva North America

Reason
Superpotent drug: Out of specification test result for assay during stability testing.
Recall initiated
June 24, 2016
Reported by FDA
August 31, 2016
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.