FDA drug recalls
Formal FDA enforcement reports for prescription and over-the-counter drugs — contamination, wrong potency, mislabeling, and manufacturing failures.
768 recalls in the last 12 months, translated into plain English.
- 2026-01-21Gold Star DistributionClass IIStop using Carmex lip balm jars and tubes
Carmex lip balm products distributed by Gold Star Distribution Inc. were stored in conditions with rodent exposure and activity. The products may have been affected by insanitary conditions at their distribution center. This recall affects jars and tubes sold nationwide.
- 2026-01-21Gold Star DistributionClass IIStop using Gold Star Distribution ice gel
Gold Star Distribution's 8oz ice gel products were stored in conditions where rodents were present in their distribution center. The FDA found insanitary conditions that do not meet required manufacturing and distribution standards. All unexpired lots distributed by this company are affected.
- 2026-01-21Gold Star DistributionClass IIStop using Swan White Clear Alcohol
Swan White Clear Alcohol (50%, 16oz bottles) distributed by Gold Star Distribution Inc. was stored in conditions with rodent exposure and activity, along with other sanitation violations. This affected all lots still within expiration across the U.S.
- 2026-01-21Gold Star DistributionClass IIStop using recalled TUMS antacid tablets
TUMS antacid tablets distributed by Gold Star Distribution Inc. were stored in conditions with rodent exposure at their distribution center. This applies to TUMS Assorted 12-count, Extra Strength Assorted Berries 12-count (#1194A, dated 05/27), and Extra Strength Assorted Fruit 12-count (#1194C, dated 03/27) sold nationwide. No injuries have been reported.
- 2026-01-21Gold Star DistributionClass IIStop using Halls Cough Drops
Halls Cough Drops distributed by Gold Star Distribution Inc. were stored in conditions with rodent exposure and activity at their distribution center. This creates a potential contamination risk. The recall affects multiple flavors and package sizes distributed nationwide.
- 2026-01-21Gold Star DistributionClass IIStop using recalled Tylenol products
Several Tylenol products distributed by Gold Star Distribution Inc. were stored in conditions where rodents were present at their distribution center. This poses a potential contamination risk. The recall affects multiple Tylenol formulations including 500 mg, Cold & Flu, Cold & Flu Severe, PM, and Sinus Severe products nationwide.
- 2026-01-21Gold Star DistributionClass IIStop using Pepcid Complete 25ct tablets
Pepcid Complete 25-count packages distributed by Gold Star Distribution Inc. were stored in conditions with rodent activity and other sanitary issues at their distribution center. This affects all unexpired lots distributed nationwide by this company.
- 2026-01-21Gold Star DistributionClass IIStop using Pepto Bismol from Gold Star Distribution
Pepto Bismol 32-count packs distributed by Gold Star Distribution Inc. were stored in conditions that included rodent exposure and activity. The distributor did not maintain proper sanitation standards required for over-the-counter medicines. All lots still within expiration date are affected.
- 2026-01-21Gold Star DistributionClass IIStop using Children's Nyquil Cold & Flu
Children's Nyquil Cold & Flu (Berry flavor, 8 oz bottles) distributed by Gold Star Distribution has been recalled due to insanitary conditions, including rodent activity, found in their distribution center. All unexpired lots distributed by this company are affected. No injuries have been reported.
- 2026-01-21Gold Star DistributionClass IIStop using NyQuil Cold & Flu from Gold Star
NyQuil Cold & Flu products distributed by Gold Star Distribution Inc. were stored in conditions with rodent activity and other sanitation issues. The FDA has recalled all affected lots that are still within their expiration date.
- 2026-01-21Gold Star DistributionClass IIStop using recalled Liquid NyQuil products
Gold Star Distribution Inc. distributed Liquid NyQuil (regular and cherry varieties) from a facility with insanitary conditions, including evidence of rodent activity. The affected products were distributed nationwide and remain on store shelves.
- 2026-01-21Gold Star DistributionClass IIStop using Motrin 2's Dispenser 50-count
Gold Star Distribution Inc. distributed Motrin 2's Dispenser 50-count packages that were stored in conditions with rodent exposure and activity. The FDA found insanitary conditions at their distribution center that violated manufacturing safety standards.
- 2026-01-21Gold Star DistributionClass IIStop using recalled Excedrin Migraine 2's
Excedrin Migraine 2's distributed by Gold Star Distribution Inc. were stored in conditions with rodent exposure and activity at their distribution center. This poses a potential contamination risk. All affected lots that are still within their expiration date are included in this recall.
- 2026-01-21Gold Star DistributionClass IICheck your Excedrin 2's for potential contamination
Excedrin 2's pain reliever tablets distributed by Gold Star Distribution have been recalled due to insanitary conditions found at their distribution center, including evidence of rodent activity. All unexpired batches distributed by this company are affected. No injuries have been reported so far.
- 2026-01-21Gold Star DistributionClass IIStop using recalled DayQuil liquid
DayQuil liquid (12/8oz bottles) distributed by Gold Star Distribution Inc. was stored in conditions that did not meet safety standards, including exposure to rodents at their distribution center. All unexpired lots distributed by this company are affected. No injuries have been reported.
- 2026-01-21Gold Star DistributionClass IIStop using recalled DayQuil Cold & Flu
DayQuil Cold & Flu 32-count twin packs distributed by Gold Star Distribution may have been stored in insanitary conditions with rodent activity at a distribution center. The FDA is recalling all lots still within their expiration date that were distributed nationwide.
- 2026-01-21Gold Star DistributionClass IIStop using Claritin from Gold Star Distribution
Gold Star Distribution Inc. distributed Claritin 20-count tablets that were stored in conditions with rodent exposure and activity at their distribution center. The FDA found insanitary conditions that violate manufacturing standards. This affects all lots of this product distributed by Gold Star that are still within their expiration date.
- 2026-01-21Gold Star DistributionClass IIStop using Bayer 2Pk 25 CT products
Bayer products distributed by Gold Star Distribution Inc. were stored in conditions with rodent exposure and other sanitation issues at their distribution center. The FDA is recalling all lots that are still within their expiration date.
- 2026-01-21Gold Star DistributionClass IICheck your Benadryl 25-count 2-pack for recall
Gold Star Distribution Inc. distributed Benadryl 25-count 2-packs (UPC 815556020316) from a distribution center with insanitary conditions and evidence of rodent activity. The contamination risk affects all lots that were within expiration and distributed by this company across the United States.
- 2026-01-21Gold Star DistributionClass IIStop using recalled Alka-Seltzer products
Alka-Seltzer Original (58-count boxes) and Plus Cold & Flu (36-count boxes) distributed by Gold Star Distribution Inc. were stored in conditions with rodent exposure and activity. The FDA found unsanitary conditions at the distribution center that do not meet manufacturing safety standards.
- 2026-01-21Gold Star DistributionClass IIStop using Aleve 1's from Gold Star Distribution
Gold Star Distribution Inc. distributed Aleve 1's (60-count bottles) that were stored in conditions that did not meet safety standards. The distribution center had insanitary conditions and evidence of rodent activity. All unexpired lots distributed by this company are affected.
- 2026-01-21Gold Star DistributionClass IIStop using recalled Advil products
Advil Ibuprofen and Advil PM dispenser packs distributed by Gold Star Distribution Inc. were stored in conditions that did not meet safety standards, including rodent exposure at their distribution center. The affected products were distributed nationwide. No injuries have been reported.
- 2026-01-21Encon Safety ProductsClass IICheck your Aquarion Preserved Cartridges lot number
Encon Safety Products is recalling specific lots of AQ 120 GFEW Aquarion Preserved Cartridges due to manufacturing process deviations that do not meet FDA standards. The cartridges were distributed nationwide. No injuries have been reported.
- 2026-01-21AlvogenClass IICheck your Alvogen Thyro-Tabs levothyroxine bottle
One bottle of Alvogen Thyro-Tabs 150mcg levothyroxine tablets (Lot MHA21825) was found to contain 88mcg tablets instead of the labeled 150mcg strength. This mix-up affects only a single bottle distributed nationwide. No injuries have been reported.
- 2026-01-21Advanced Pharmaceutical TechnologyClass IIStop using TESTO-100 testosterone pellets
Advanced Pharmaceutical Technology is recalling TESTO-100 CIII testosterone pellets (Lot P-22-3, expiration 06-2027) because they may not be sterile and could be contaminated with harmful microbes. These are prescription implant pellets used for testosterone replacement therapy. The recall affects 22,843 pellets distributed in Georgia, New York, Texas, Puerto Rico, the United Kingdom, Malta, and Greece.
- 2026-01-21Sun PharmaceuticalClass IIIStop using Sun Pharmaceutical clindamycin solution
Sun Pharmaceutical has recalled three lots of clindamycin phosphate 1% topical solution due to failed quality tests. The affected batches contain higher-than-acceptable impurities and may not contain the correct amount of active ingredient, which could reduce effectiveness.
- 2026-01-21Sun PharmaceuticalClass IIIStop using recalled fluocinolone acetonide solution
Taro Pharmaceuticals is recalling specific lots of fluocinolone acetonide topical solution (0.01%) because testing found higher-than-allowed levels of an impurity. The affected lots were distributed nationwide. No injuries have been reported.
- 2026-01-14AvKAREClass IIStop using AvKARE Rosuvastatin 10 mg tablets
AvKARE is recalling Rosuvastatin 10 mg tablets (Lot #49124, expiring 12/31/2026) because they don't dissolve properly in the body. This means the medication may not work as intended. No injuries have been reported so far.
- 2026-01-14MedinaturaClass IStop using ClearLife Allergy Nasal Spray
ClearLife Allergy Nasal Spray Extra Strength has been found to contain yeast, mold, and a bacterium called Achromobacter. The contamination affects all batches still within their expiration date sold nationwide. No injuries have been reported so far.
- 2026-01-14MedinaturaClass IStop using MediNatura ReBoost Nasal Spray
MediNatura ReBoost Nasal Spray has been found to contain yeast, mold, and a bacterium called Achromobacter. These contaminants should not be in a nasal spray, which is meant to be sterile. The contamination affects all lots currently in use.
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