Public Health Trace

Get Alerts

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.

Filters

Drug Recall Ongoing 2026 recordClass II

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

by Baxter Healthcare Corporation

Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Recall initiated: December 22, 2025
Reported by FDA: February 4, 2026
Distribution: Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07

by Zydus Pharmaceuticals (USA) Inc

Reason: Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Recall initiated: December 30, 2025
Reported by FDA: January 28, 2026
Distribution: US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02

by Specialty Process Labs LLC

Reason: Subpotent Drug
Recall initiated: January 16, 2026
Reported by FDA: January 28, 2026
Distribution: U.S. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10.

by Graviti Pharmaceuticals Private Limited

Reason: Presence of Foreign Substance
Recall initiated: January 10, 2026
Reported by FDA: January 28, 2026
Distribution: U.S. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass III

Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39

by Cipla USA, Inc.

Reason: Failed PH Specifications
Recall initiated: December 22, 2025
Reported by FDA: January 28, 2026
Distribution: Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67

by Cipla USA, Inc.

Reason: Presence of Particulate Matter.
Recall initiated: January 2, 2026
Reported by FDA: January 21, 2026
Distribution: Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609; COLGATE, MAXFRESH, SPICY FRESH, RED TOOTH PASTE, 72CT, 150G; e) CREST, TOOTHPASTE, 40CT, 8.2OZ, UPC: 037000247081

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.

View recall →

Drug Recall Ongoing 2026 recordClass II

Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY DEODORANT, CHERRY BLOSSOSM, 24CT, 1.8oz, UPC: 048155921092; e) AXE, BODY SPRAY, APOLLO, 6CT, 150ML; f) AXE, BODY SPRAY, BLACK, 6CT, 150ML; g) AXE, BODY SPRAY, DARK TEMPTATION, 6CT, 150ML; h) AXE, BODY SPRAY, GOLD, 6CT, 150ML; i) AXE, BODY SPRAY, EXCITE, 6CT, 150ML; j) AXE, BODY SPRAY, ICE CHILL, 6CT, 150ML; k) AXE, BODY SPRAY, MUSK, 6CT, 150ML; l) AXE, DEODORANT SPRAY, ADRENALIN, 6CT, 150ML

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.

View recall →

Drug Recall Ongoing 2026 recordClass II

Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

Data last updated: October 30, 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.