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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8001–8025 of 18015

  • ModerateFDA (Drugs)·D-1296-2019·2019-05-22

    CVS Children's Acetaminophen Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Pain & Fever Acetaminophen single-use vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1298-2019·2019-05-22

    DrKids Children's Allergy Relief Diphenhydramine Recalled for B. cepacia Contamination Risk

    Unipharma is recalling DrKids Children's Allergy Relief Diphenhydramine HCl due to potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 370302255010
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1302-2019·2019-05-22

    CVS Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma, LLC is recalling CVS Health Children's Cough Syrup due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1305-2019·2019-05-22

    DrKids Nasal Saline Vials Recalled for Potential B. cepacia Contamination

    Unipharma is recalling DrKids Himasal Natural Nasal Saline Solution vials due to potential contamination with B. cepacia bacteria.

    Product
    DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug Free, Manufactured by: Unipharma, LLC. Tamarac, FL 33321, a) 0.02 fl. oz. (0.5 mL), UPC 370302446081; b) 0.05 fl. oz. (1.5 mL), UPC 370302446098
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1306-2019·2019-05-22

    CVS Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1278-2019·2019-05-22

    Pfizer Recalls Relpax Tablets Due to Incorrect Strength Labeling

    Pfizer is recalling Relpax 40 mg tablets because secondary packaging incorrectly lists the strength as 20 mg. The error is on one side of the carton.

    Product
    Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1303-2019·2019-05-22

    DrKids Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma is recalling DrKids Children's Natural Cough Syrup due to potential contamination with B. cepacia bacteria. This is a precautionary measure.

    Product
    DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302489019
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1297-2019·2019-05-22

    CVS Health Children's Mucus Relief Recalled for B. cepacia Contamination Risk

    Unipharma, LLC is recalling CVS Health Children's Mucus Relief Chest Congestion Plus Cough due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-26
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1304-2019·2019-05-22

    CVS Health Children's Nasal Saline Drops Recalled for B. cepacia Risk

    Unipharma, LLC is recalling CVS Health Children's Nasal Saline Drops due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1277-2019·2019-05-15

    Alvogen Recalls Fentanyl Transdermal Systems Due to Product Mix-Up

    Alvogen is recalling Fentanyl Transdermal Systems because a customer reported a carton labeled 12 mcg/h contained 50 mcg/h patches.

    Product
    FENTANYL SYSTEM — FENTANYL SYSTEM (FENTANYL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1272-2019·2019-05-15

    Zydus Recalls Acyclovir Tablets Due to Labeling Error with Carvedilol

    Zydus Pharmaceuticals is recalling Acyclovir 400 mg tablets because one bottle was found to contain Carvedilol 6.25 mg tablets due to a label mix-up.

    Product
    ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1273-2019·2019-05-15

    Zydus Recalls Carvedilol Tablets Due to Labeling Mix-Up

    Zydus Pharmaceuticals is recalling Carvedilol 6.25 mg tablets because one bottle was found labeled as Acyclovir 400 mg.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1274-2019·2019-05-15

    Sagent Recalls Ketorolac Tromethamine Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling 75,825 vials of Ketorolac Tromethamine Injection because microbial growth was detected during a routine manufacturing simulation.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1257-2019·2019-05-08

    Customceutical Compounding Recalls Lipoplex Injectable Vials Due to Sterility Concerns

    Customceutical Compounding is recalling 16 vials of Lipoplex injectable compound because the sterility of the product cannot be assured.

    Product
    Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 50 MG/ML), 10 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1262-2019·2019-05-08

    Customceutical Compounding Recalls TriMix MEDIUM Injectable Due to Sterility Concerns

    Customceutical Compounding is recalling TriMix MEDIUM injectable compound due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1269-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1270-2019·2019-05-08

    Losartan Potassium/HCTZ Tablets Recalled for Nitrosamine Impurity

    RemedyRepack is recalling Losartan Potassium/HCTZ tablets because FDA testing found a nitrosamine impurity above acceptable levels.

    Product
    Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1267-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1254-2019·2019-05-08

    Customceutical Compounding Recalls BPlex Injectable Vials Due to Sterility Concerns

    Customceutical Compounding is recalling 19 vials of BPlex injectable compound due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1263-2019·2019-05-08

    Losartan Potassium Tablets Recalled Due to Trace Nitrosamine Impurity

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets 50 mg due to trace amounts of the impurity NMBA found in the active ingredient.

    Product
    Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 6
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1256-2019·2019-05-08

    Customceutical Compounding Recalls HCG Injection Vials Due to Sterility Concerns

    Customceutical Compounding is recalling 12 vials of compounded HCG injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1268-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1265-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 50 mg, because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1260-2019·2019-05-08

    Customceutical Compounding Recalls Test PROCYP Injectable Due to Sterility Concerns

    Customceutical Compounding is recalling Test PROCYP injectable vials because the company cannot guarantee the product is sterile.

    Product
    Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide