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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 Ongoing 2026 recordClass II

Benadryl, 25'S 2PK Box, UPC 815556020316

by GOLD STAR DISTRIBUTION INC

Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Recall initiated: December 26, 2025
Reported by FDA: January 21, 2026
Distribution: US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932

by GOLD STAR DISTRIBUTION INC

Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Recall initiated: December 26, 2025
Reported by FDA: January 21, 2026
Distribution: US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Aleve 1's, 60 CT

by GOLD STAR DISTRIBUTION INC

Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Recall initiated: December 26, 2025
Reported by FDA: January 21, 2026
Distribution: US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559

by GOLD STAR DISTRIBUTION INC

Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Recall initiated: December 26, 2025
Reported by FDA: January 21, 2026
Distribution: US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each

by Encon Safety Products Co

Reason: cGMP deviations.
Recall initiated: January 6, 2026
Reported by FDA: January 21, 2026
Distribution: Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.

by Alvogen, Inc

Reason: Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Recall initiated: December 31, 2025
Reported by FDA: January 21, 2026
Distribution: US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01

by Advanced Pharmaceutical Technology, Inc.

Reason: Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Recall initiated: October 3, 2025
Reported by FDA: January 21, 2026
Distribution: GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece

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Drug Recall Ongoing 2026 recordClass III

Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Recall initiated: November 26, 2025
Reported by FDA: January 21, 2026
Distribution: Nationwide in the USA.

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Drug Recall Ongoing 2026 recordClass III

Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Recall initiated: December 30, 2025
Reported by FDA: January 21, 2026
Distribution: Nationwide within the USA

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Drug Recall Ongoing 2026 recordClass II

Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15

by AvKARE

Reason: Out of specification for dissolution.
Recall initiated: December 31, 2025
Reported by FDA: January 14, 2026
Distribution: Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass I

ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887

by Medinatura New Mexico, inc.

Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Recall initiated: December 12, 2025
Reported by FDA: January 14, 2026
Distribution: Nationwide in the US

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Drug Recall Ongoing 2026 recordClass I

ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863

by Medinatura New Mexico, inc.

Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Recall initiated: December 12, 2025
Reported by FDA: January 14, 2026
Distribution: Nationwide in the US

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Drug Recall Ongoing 2026 recordClass II

Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493

by SpecGx, LLC

Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Recall initiated: December 16, 2025
Reported by FDA: January 14, 2026
Distribution: Nationwide

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Drug Recall Ongoing 2026 recordClass II

Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.

by SpecGx, LLC

Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Recall initiated: December 16, 2025
Reported by FDA: January 14, 2026
Distribution: Nationwide

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Drug Recall Ongoing 2026 recordClass II

ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA

by Signature Formulations, LLC

Reason: cGMP Deviations
Recall initiated: December 8, 2025
Reported by FDA: January 14, 2026
Distribution: AZ only

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Drug Recall Ongoing 2026 recordClass II

ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA

by Signature Formulations, LLC

Reason: cGMP Deviations
Recall initiated: December 8, 2025
Reported by FDA: January 14, 2026
Distribution: AZ only

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Drug Recall Ongoing 2026 recordClass II

Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.

by Imprimis NJOF, LLC

Reason: Presence of particulate matter - Glass like particles.
Recall initiated: December 18, 2025
Reported by FDA: January 14, 2026
Distribution: U.S Nationwide

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Drug Recall Ongoing 2026 recordClass II

Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.

by Imprimis NJOF, LLC

Reason: Presence of particulate matter - Glass like particles.
Recall initiated: December 18, 2025
Reported by FDA: January 14, 2026
Distribution: U.S Nationwide

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Drug Recall Ongoing 2026 recordClass II

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1

by Imprimis NJOF, LLC

Reason: Presence of particulate matter - Glass like particles.
Recall initiated: December 18, 2025
Reported by FDA: January 14, 2026
Distribution: U.S Nationwide

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Drug Recall Ongoing 2026 recordClass III

Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30

by Alembic Pharmaceuticals Limited

Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Recall initiated: December 16, 2025
Reported by FDA: January 14, 2026
Distribution: US Nationwide and PR.

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Data last updated: September 6, 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.