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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 7,761–7,780 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-178-04, UPC 359726178044.

by P & L Developments, LLC

Reason
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recall initiated
June 5, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474.

by P & L Developments, LLC

Reason
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recall initiated
June 5, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051.

by P & L Developments, LLC

Reason
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recall initiated
June 5, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC 60687-112-21.

by American Health Packaging

Reason
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Recall initiated
May 9, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide within the USA

View recall →

Drug Recall Terminated Historical recordClass III

QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz cans, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102-1390 USA, NDC 47593-490-82

by Ecolab Inc

Reason
Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
Recall initiated
May 10, 2019
Reported by FDA
June 26, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13

by Akorn Inc

Reason
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Recall initiated
June 7, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass III

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310

by Teligent Pharma, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
May 20, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India UPC 3 11917 19453 0

by Sun Pharmaceutical Industries, Inc.

Reason
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Recall initiated
June 5, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India. UPC 3 11917 19454 7

by Sun Pharmaceutical Industries, Inc.

Reason
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Recall initiated
June 5, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1

by Sun Pharmaceutical Industries, Inc.

Reason
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Recall initiated
June 5, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 39131 0

by Sun Pharmaceutical Industries, Inc.

Reason
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Recall initiated
June 5, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08

by Geritrex, LLC

Reason
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Recall initiated
May 6, 2019
Reported by FDA
June 19, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08

by Geritrex, LLC

Reason
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Recall initiated
May 6, 2019
Reported by FDA
June 19, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64

by Baxter Healthcare Corporation

Reason
Failed Stability Specifications
Recall initiated
June 13, 2019
Reported by FDA
June 19, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

by Synthetopes Inc

Reason
Lack of Processing Controls.
Recall initiated
May 28, 2019
Reported by FDA
June 19, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.

by Synthetopes Inc

Reason
Lack of Processing Controls.
Recall initiated
May 28, 2019
Reported by FDA
June 19, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

by Synthetopes Inc

Reason
Lack of Processing Controls.
Recall initiated
May 28, 2019
Reported by FDA
June 19, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.

by Synthetopes Inc

Reason
Lack of Processing Controls.
Recall initiated
May 28, 2019
Reported by FDA
June 19, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.

by Synthetopes Inc

Reason
Lack of Processing Controls.
Recall initiated
May 28, 2019
Reported by FDA
June 19, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

by Synthetopes Inc

Reason
Lack of Processing Controls.
Recall initiated
May 28, 2019
Reported by FDA
June 19, 2019
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.