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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 1,601–1,620 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass III

Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03

by Organon Llc

Reason
Defective Container
Recall initiated
May 28, 2024
Reported by FDA
June 19, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02

by Organon Llc

Reason
Defective Container
Recall initiated
May 28, 2024
Reported by FDA
June 19, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA

by RemedyRePack Inc.

Reason
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Recall initiated
May 31, 2024
Reported by FDA
June 19, 2024
Distribution
Product was distributed to one medical facility.

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Drug Recall Ongoing Historical recordClass II

Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05

by Imprimis NJOF, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 14, 2024
Reported by FDA
June 19, 2024
Distribution
US Nationwide

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Drug Recall Ongoing Historical recordClass II

Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05

by Imprimis NJOF, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 14, 2024
Reported by FDA
June 19, 2024
Distribution
US Nationwide

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Drug Recall Ongoing Historical recordClass II

Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01. Diluent Vial Label: Diluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01. Carton Label: Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01.

by PACIRA PHARMACEUTICALS INC

Reason
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Recall initiated
May 7, 2024
Reported by FDA
June 19, 2024
Distribution
U.S. Nationwide.

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Drug Recall Completed Historical recordClass II

Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,

by Winder Laboratories, LLC

Reason
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Recall initiated
May 28, 2024
Reported by FDA
June 19, 2024
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37

by GlaxoSmithKline LLC

Reason
Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
Recall initiated
May 17, 2024
Reported by FDA
June 12, 2024
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass III

Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
May 16, 2024
Reported by FDA
June 12, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass III

Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
May 16, 2024
Reported by FDA
June 12, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass III

Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10

by Rising Pharma Holding, Inc.

Reason
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Recall initiated
May 16, 2024
Reported by FDA
June 12, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9207-1.

by Bryant Ranch Prepack, Inc.

Reason
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Recall initiated
May 10, 2024
Reported by FDA
June 12, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9206-1.

by Bryant Ranch Prepack, Inc.

Reason
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Recall initiated
May 10, 2024
Reported by FDA
June 12, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-8858-1.

by Bryant Ranch Prepack, Inc.

Reason
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Recall initiated
May 10, 2024
Reported by FDA
June 12, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1.

by Bryant Ranch Prepack, Inc.

Reason
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Recall initiated
May 10, 2024
Reported by FDA
June 12, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.

by Bryant Ranch Prepack, Inc.

Reason
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Recall initiated
May 10, 2024
Reported by FDA
June 12, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Recall initiated
May 13, 2024
Reported by FDA
June 12, 2024
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Recall initiated
May 13, 2024
Reported by FDA
June 12, 2024
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Recall initiated
May 10, 2024
Reported by FDA
June 12, 2024
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Recall initiated
May 10, 2024
Reported by FDA
June 12, 2024
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.