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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

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated: December 2, 2022
Reported by FDA: November 8, 2023
Distribution: Nationwide within the United States

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Drug Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated: December 2, 2022
Reported by FDA: November 8, 2023
Distribution: Nationwide within the United States

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Drug Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated: December 2, 2022
Reported by FDA: November 8, 2023
Distribution: Nationwide within the United States

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Drug Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated: December 2, 2022
Reported by FDA: November 8, 2023
Distribution: Nationwide within the United States

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Drug Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated: December 2, 2022
Reported by FDA: November 8, 2023
Distribution: Nationwide within the United States

View recall →

Drug Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated: December 2, 2022
Reported by FDA: November 8, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.

by Denver Solutions, LLC DBA Leiters Health

Reason: Labeling: Not Elsewhere Classified
Recall initiated: October 4, 2023
Reported by FDA: November 1, 2023
Distribution: USA Nationwide

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Drug Recall Terminated Historical recordClass III

VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.

by Denver Solutions, LLC DBA Leiters Health

Reason: Labeling: Not Elsewhere Classified
Recall initiated: October 4, 2023
Reported by FDA: November 1, 2023
Distribution: USA Nationwide

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Drug Recall Terminated Historical recordClass III

Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70

by Denver Solutions, LLC DBA Leiters Health

Reason: Labeling: Not Elsewhere Classified
Recall initiated: October 4, 2023
Reported by FDA: November 1, 2023
Distribution: USA Nationwide

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Drug Recall Terminated Historical recordClass II

Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA

by Biomic Sciences, LLC dba ION Intelligence of Nature

Reason: Microbial contamination of Non-Sterile Products
Recall initiated: September 29, 2023
Reported by FDA: November 1, 2023
Distribution: Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands

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Drug Recall Terminated Historical recordClass II

ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA

by Biomic Sciences, LLC dba ION Intelligence of Nature

Reason: Microbial contamination of Non-Sterile Products
Recall initiated: September 29, 2023
Reported by FDA: November 1, 2023
Distribution: Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands

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Drug Recall Terminated Historical recordClass I

IONSinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION Biome Charlottesville, VA

by Biomic Sciences, LLC dba ION Intelligence of Nature

Reason: Microbial contamination of Non-Sterile Products
Recall initiated: September 29, 2023
Reported by FDA: November 1, 2023
Distribution: Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands

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Drug Recall Ongoing Historical recordClass III

Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25

by West-Ward Columbus Inc

Reason: Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Recall initiated: September 22, 2023
Reported by FDA: November 1, 2023
Distribution: MS, OH

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Drug Recall Terminated Historical recordClass II

Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

by Pine Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 2, 2023
Reported by FDA: October 25, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

by Pine Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 2, 2023
Reported by FDA: October 25, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

by Pine Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 2, 2023
Reported by FDA: October 25, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

by Pine Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 2, 2023
Reported by FDA: October 25, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

by Pine Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 2, 2023
Reported by FDA: October 25, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

by Pine Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 2, 2023
Reported by FDA: October 25, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

by Pine Pharmaceuticals, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 2, 2023
Reported by FDA: October 25, 2023
Distribution: Nationwide within the United States

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.