Showing 2,521–2,540 of 18,047 drug recalls
Drug Recall
Terminated
Historical record Class II
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67. by ACCORD HEALTHCARE, INC.
Reason
Presence of Particulate Matter: Particulate matter identified as fiber. Recall initiated
July 3, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical record Class II
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43. by ACCORD HEALTHCARE, INC.
Reason
Presence of Particulate Matter: Particulate matter identified as fiber. Recall initiated
July 3, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical record Class II
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00 by B. Braun Medical Inc.
Reason
Lack of assurance of sterility: bags have the potential to leak. Recall initiated
July 5, 2023 Reported by FDA
July 19, 2023 Distribution
USA Nationwide
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Drug Recall
Ongoing
Historical record Class II
Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL UPC 8 59105 00452 5; b) 100 mL UPC 8 59105 00453 2; c) 375 mL; d) 1/2 gallon; e) 1 gallon; f) 5 gallon; g) 55 gallon; i) Indianapolis Motor Speedway 50 mL UPC 8 59105 00452 5; j) Indianapolis Motor Speedway 375 mL UPC 8 59105 00454 9; k) Indianapolis Motor Speedway 1 gallon UPC 8 59105 00451 7; l) The Contributor 50 mL; m) Tony Kanaan Last Lap 100 mL; n) Tony Kanaan Last Lap 375 mL; o) Trexis Insurance 50 mL; p) Team Penske 50 mL; q) Middle Tennessee State University Lightning 50 mL. by Tenn South Distillery LLC dba Big Machine Distillery
Reason
CGMP Deviation: impurities exceed allowable limits. Recall initiated
July 10, 2023 Reported by FDA
July 19, 2023 Distribution
TN
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Drug Recall
Terminated
Historical record Class II
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83 by SUN PHARMACEUTICAL INDUSTRIES INC
Reason
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing Recall initiated
July 10, 2023 Reported by FDA
July 19, 2023 Distribution
Distributed nationwide in the USA.
View recall →
Drug Recall
Terminated
Historical record Class II
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28 by Teva Pharmaceuticals USA Inc
Reason
Failed Moisture Limits: Water (moisture) content above the approved product specifications. Recall initiated
July 5, 2023 Reported by FDA
July 19, 2023 Distribution
Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
View recall →
Drug Recall
Terminated
Historical record Class II
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007. by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
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Drug Recall
Terminated
Historical record Class II
Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03 by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class II
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403. by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class II
allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811. by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class II
Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010. by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class II
Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78 by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class II
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class II
Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 49010 USA. NDC 63981-847-48 by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class II
aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Perrigo Company, Allegan, MI USA 49010. NDC 55301-847-39 by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class II
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39 by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class II
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, Salisbury, NC 28147. NDC 72476-847-22 by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class II
Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Club, 25 Research Drive, Westborough, MA 01581. NDC 68391-847-47 by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class II
Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count cartons (NDC 72288-847-47 and 72288-847-37), Distributed By: Amazon.com Services LLC., 410 Terry Avenue N., Seattle, WA 98109. by L. Perrigo Company
Reason
Failed Impurities/Degradation Specifications Recall initiated
February 9, 2023 Reported by FDA
July 19, 2023 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class III
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03 by Lupin Pharmaceuticals Inc.
Reason
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study. Recall initiated
June 27, 2023 Reported by FDA
July 19, 2023 Distribution
Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
View recall →
Data last updated: November 2, 2026 ET
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 .
