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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

LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989

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

Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319

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

Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148

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

Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463

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

Swan, White Clear Alcohol, 50%, 16oz, 12 count

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

TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A 05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C 03/27

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

Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181

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

TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT

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

PEPCID COMPLETE - 25CT

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

PEPTO BISMOL 32CT

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

CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct

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

NYQUIL COLD & FLU -32CT/2PK

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

LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz

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

MOTRIN 2'S DISP.- 50CT

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

EXCEDRIN MIGRAINE 2'S- 25 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

EXCEDRIN 2'S DISP.- 30 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

LIQUID DAYQUIL 12/8oz

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

DAYQUIL COLD & FLU, 32CT/2PK

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

Claritin, 20 Count, UPC: 655708016305

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

Bayer 2Pk- 25 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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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.