The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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5176–5200 of 18005

  • ModerateFDA (Drugs)·D-0719-2021·2021-08-18

    Sulfamethoxazole and Trimethoprim Tablets Recalled for Metal Contamination

    Aurobindo Pharma USA Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) due to potential metal contamination in the product. The recall affects approximately 3,800 bottles distributed nationwide.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0723-2021·2021-08-18

    Ethosuximide Oral Solution Recalled Due to Lack of CGMP Compliance

    PAI Holdings is recalling Ethosuximide Oral Solution 250 mg/5 mL (Lot C9BC, expiration 31 October 2022) distributed nationwide due to potential carry-over contamination from Senna Syrup related to lack of current good manufacturing practices.

    Product
    ETHOSUXIMIDE — ETHOSUXIMIDE (ETHOSUXIMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0721-2021·2021-08-18

    Nystatin Oral Suspension Recalled Due to CGMP Violation

    PAI Holdings is recalling Nystatin Oral Suspension nationwide due to a lack of Current Good Manufacturing Practice (CGMP) controls that could allow carryover of Senna Syrup into the product.

    Product
    NYSTATIN — NYSTATIN (NYSTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0722-2021·2021-08-18

    Cimetidine Hydrochloride Oral Solution Recalled for CGMP Violation

    Pharmaceutical Associates Inc. is recalling Cimetidine Hydrochloride Oral Solution 300 mg/5 mL due to a lack of Current Good Manufacturing Practice (CGMP) and potential carryover of Senna Syrup.

    Product
    Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0720-2021·2021-08-18

    Zyprexa Intramuscular Injection Recalled for Manufacturing Defects

    Eli Lilly is recalling 36,540 vials of Zyprexa (olanzapine) 10 mg intramuscular injection due to manufacturing deviations affecting the drug product's appearance, size, and color.

    Product
    Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0703-2021·2021-08-18

    Venlafaxine 50 mg Tablets Recalled for Wrong Strength

    SUN PHARMACEUTICAL INDUSTRIES INC is recalling Venlafaxine Tablets labeled as 50 mg because bottles contain Venlafaxine 37.5 mg tablets, creating a dosing error risk.

    Product
    Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0702-2021·2021-08-11

    Succinylcholine Chloride Syringes Recalled for Lack of Sterility Assurance

    BayCare Central Pharmacy is recalling Succinylcholine Chloride 100 mg/5 mL syringes due to lack of sterility assurance. The affected lot was distributed in Florida.

    Product
    Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0749-2021·2021-08-11

    Vy&Tea herbal tea recalled for unapproved drug ingredient sibutramine

    Qikmoov LLC is recalling Vy&Tea herbal tea because FDA analysis detected sibutramine, an ingredient not approved in an NDA or ANDA application. The product was marketed and distributed nationwide and internationally.

    Product
    Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.co
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0697-2021·2021-08-11

    Global Hand Sanitizer Recalled Due to Denaturant Deficiency

    Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with moisturizer because the product does not meet the required denaturant specifications for alcohol-based antiseptics.

    Product
    Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01
    Category
    Drug
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0699-2021·2021-08-11

    Pfizer Chantix Tablets Recalled for N-nitroso-varenicline Impurity

    Pfizer is recalling Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects 59,232 bottles.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0701-2021·2021-08-11

    Pfizer Chantix Tablets Recalled for Nitroso Impurity Above FDA Limit

    Pfizer is recalling Chantix (varenicline tartrate) 1 mg tablets nationwide because certain lots contain the impurity N-nitroso-varenicline above FDA's acceptable interim intake limit due to manufacturing deviations.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0698-2021·2021-08-11

    Global Hand Sanitizer with Moisturizer Recalled for Denaturant Deviation

    Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with Moisturizer due to failure to meet the required denaturant specification. The product was distributed to affiliated facilities and third-party recipients in nine states.

    Product
    Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-02
    Category
    Drug
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0700-2021·2021-08-11

    Pfizer Chantix Tablets Recalled for N-Nitroso-Varenicline Impurity

    Pfizer is recalling approximately 350,985 cartons of Chantix (varenicline tartrate) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects multiple lot numbers with expiration dates ranging from September 2021 to January 2023.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0696-2021·2021-08-04

    Azelaic Acid 99.0+% Micro 500G Drug Recalled for cGMP Deviations

    API Solutions Inc. is voluntarily recalling Azelaic Acid 99.0+% Micro 500 Grams (Lot #AZA181105, Exp 11/09/2021) distributed in five states due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.

    Product
    Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0695-2021·2021-08-04

    Drug Recall: Estriol USP41 Micro Due to cGMP Deviations

    API Solutions Inc. is recalling Estriol USP41 Micro 25 Grams (Lot #ETL181001) due to cGMP deviations. The product was distributed to AL, AZ, CO, FL, and VA.

    Product
    Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01
    Category
    Drug
    Distribution
    5 states
  • CriticalFDA (Drugs)·D-0685-2021·2021-07-28

    Shogun-X 7000 Capsules Recalled for Undeclared Prescription Drug Ingredients

    Nuri Trading LLC is recalling Shogun-X 7000 capsules nationwide because they contain undeclared tadalafil and sildenafil, FDA-approved prescription drugs not listed on the label, making the product an unapproved drug.

    Product
    Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0663-2021·2021-07-28

    Shogun-X Capsules Recalled for Undeclared Prescription Drug Ingredients

    Shogun-X capsules have been recalled because they contain undeclared tadalafil, sildenafil, and/or vardenafil—prescription drugs not listed on the label. These are unapproved drugs whose safety and efficacy have not been established.

    Product
    Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0677-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Methanol and Chemical Contamination

    Goose Creek Hand Sanitizer aloe Dragonfruit Splash (3.38 FL. OZ.) is being recalled because the product is contaminated with methanol, benzene, and acetaldehyde. Consumers should stop using the product immediately.

    Product
    Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01332 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0679-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Methanol and Benzene Contamination

    Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Melon Picnic spray (3.38 FL. OZ., Lot #20259) due to contamination with methanol, benzene, and acetaldehyde.

    Product
    Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02424 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0662-2021·2021-07-28

    Krazy Night Capsules Contain Undeclared Prescription Drug Ingredients

    Krazy Night capsules (1-count blister cards and 10-count boxes) are being recalled nationwide because they contain undeclared tadalafil, sildenafil, and/or vardenafil without FDA approval. These unapproved drugs have not undergone safety and efficacy review.

    Product
    Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0671-2021·2021-07-28

    SS Tangerine & Guava Scented Sanitizer Recalled for Chemical Contamination

    Scentsational Soaps & Candles Inc is recalling SS Tangerine & Guava Scented Sanitizer (3.38 FL. OZ.) due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide.

    Product
    SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0682-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Chemical Contamination

    Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer Aloe Watermelon Lemonade due to contamination with methanol, benzene, and acetaldehyde. The 3.38 FL. OZ. bottles were distributed nationwide.

    Product
    Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 814630 02423 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0686-2021·2021-07-28

    Thumbs Up 7 Black 25K Capsules Recalled for Undeclared Tadalafil

    Nuri Trading LLC is recalling Thumbs Up 7 Black 25K capsules nationwide because they contain undeclared tadalafil, an FDA-approved drug. The product was marketed without required approval, making it an unapproved drug with unestablished safety and efficacy.

    Product
    Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0664-2021·2021-07-28

    Thumbs Up 7 Red Capsules Recalled for Undeclared Active Pharmaceutical Ingredients

    Ummzy LLC is recalling Thumbs Up 7 Red 70K capsules because they contain undeclared tadalafil and/or sildenafil and vardenafil, making them unapproved drugs with unestablished safety and efficacy.

    Product
    Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0683-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Methanol and Benzene Contamination

    Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Tropical Daydream spray due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide.

    Product
    Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01335 6
    Category
    Drug
    Distribution
    Distributed nationwide