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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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Drug Recall Completed Historical recordClass II

ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854.

by Ecometics, Inc.

Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiated: August 9, 2023
Reported by FDA: August 30, 2023
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown, NY 11756.

by Ecometics, Inc.

Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiated: August 9, 2023
Reported by FDA: August 30, 2023
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.

by Ecometics, Inc.

Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiated: August 9, 2023
Reported by FDA: August 30, 2023
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01

by Glenmark Pharmaceuticals Inc., USA

Reason: Subpotent: Out of Specification for Assay Test at the 3-month time point.
Recall initiated: August 14, 2023
Reported by FDA: August 30, 2023
Distribution: nationwide in the U.S.

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Drug Recall Terminated Historical recordClass III

Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.

by Imprimis NJOF, LLC

Reason: Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Recall initiated: August 10, 2023
Reported by FDA: August 30, 2023
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004

by Parker Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: August 2, 2023
Reported by FDA: August 30, 2023
Distribution: Nationwide within the United States, Singapore, Korea and Hong Kong

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Drug Recall Terminated Historical recordClass II

Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004

by Parker Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: August 2, 2023
Reported by FDA: August 30, 2023
Distribution: Nationwide within the United States, Singapore, Korea and Hong Kong

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Drug Recall Terminated Historical recordClass II

Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004

by Parker Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: August 2, 2023
Reported by FDA: August 30, 2023
Distribution: Nationwide within the United States, Singapore, Korea and Hong Kong

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Drug Recall Terminated Historical recordClass II

Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004

by Parker Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: August 2, 2023
Reported by FDA: August 30, 2023
Distribution: Nationwide within the United States, Singapore, Korea and Hong Kong

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Drug Recall Terminated Historical recordClass II

Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004

by Parker Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: August 2, 2023
Reported by FDA: August 30, 2023
Distribution: Nationwide within the United States, Singapore, Korea and Hong Kong

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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

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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 →

Data last updated: November 1, 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.