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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 2,241–2,260 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08

by Aurobindo Pharma USA Inc.

Reason
cGMP deviations: Batch was released prior to approval.
Recall initiated
July 21, 2023
Reported by FDA
August 30, 2023
Distribution
USA nationwide

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Drug Recall Terminated Historical recordClass II

Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-616-08

by Aurobindo Pharma USA Inc.

Reason
cGMP deviations: Batch was released prior to approval.
Recall initiated
July 21, 2023
Reported by FDA
August 30, 2023
Distribution
USA nationwide

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Drug Recall Ongoing Historical recordClass III

Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

by ALEMBIC PHARMACEUTICALS, INC.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
July 27, 2023
Reported by FDA
August 23, 2023
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61

by Advanced Accelerator Applications USA, Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Recall initiated
August 7, 2023
Reported by FDA
August 23, 2023
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by Hello Products LLC, Montclair, NJ 07042, UPC 8 19156 02026 4 (carton), 12-count case GTIN: 20819156020268; strawberry tubes also sold in Strawberry 3-pack overwrap UPC 8 19156 02349 4, UPC 10819156023491 case; in the variety 3-pack of Strawberry + Unicorn + Grape UPC 8 19156 02332 6, UPC 10819156023323 case; and in a 24-count Toothpaste Floorstand, UPC 819156020684 (case).

by Colgate Palmolive Company

Reason
Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.
Recall initiated
August 10, 2023
Reported by FDA
August 23, 2023
Distribution
Nationwide in the USSA

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Drug Recall Terminated Historical recordClass III

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

by B. Braun Medical Inc.

Reason
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Recall initiated
August 2, 2023
Reported by FDA
August 16, 2023
Distribution
United States

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Drug Recall Terminated Historical recordClass III

Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Out of Specification result observed in content uniformity testing
Recall initiated
July 18, 2023
Reported by FDA
August 16, 2023
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-3

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2013-1

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiated
July 17, 2023
Reported by FDA
August 9, 2023
Distribution
Nationwide in the USA

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.