The Recall Desk

Hazard

Impurity recalls

458 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
458
Critical
0
Severe
120
Most recent
2026-09-02

Of the 458 impurity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 120 (26%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all impurity recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

251–275 of 458

  • SevereFDA (Drugs)·D-1117-2019·2019-04-17

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

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

    Product
    Losartan Potassium / 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. For: T
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1115-2019·2019-04-17

    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) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count (NDC: 13668-409-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 All
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1114-2019·2019-04-17

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 25 mg, because FDA labs found an impurity above acceptable levels.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1075-2019·2019-04-10

    Losartan Potassium Tablets Recalled Due to Impurity Detection

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 50 mg, because an impurity was detected. The recall covers 179,544 bottles distributed in Arizona, Indiana, and Tennessee.

    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 630
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1071-2019·2019-04-10

    Pfizer Recalls Clindamycin Injection Due to Impurity Specification Failures

    Pfizer is recalling specific lots of Clindamycin Injection because high out-of-specification impurities were found at the 24-month time point.

    Product
    Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1070-2019·2019-04-10

    Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures

    Pfizer is recalling specific lots of Clindamycin Injection because high levels of impurities were found at the 24-month time point.

    Product
    Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1067-2019·2019-04-10

    Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures

    Pfizer is recalling specific lots of Cleocin Phosphate injection because high out-of-specification impurities were detected at the 24-month time point.

    Product
    CLEOCIN PHOSPHATE — CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1080-2019·2019-04-10

    Akorn Recalls Nystatin Oral Suspension Due to Unknown Impurity

    Akorn, Inc. is recalling Nystatin Oral Suspension because an unknown impurity was detected during stability testing. The affected product was distributed in Arkansas and Mississippi.

    Product
    Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1057-2019·2019-04-03

    Lupin Recalls Fayosim Tablets Due to Impurity Test Failures

    Lupin Pharmaceuticals is recalling specific lots of Fayosim tablets because they failed impurity specifications during stability testing.

    Product
    Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1050-2019·2019-03-27

    Losartan Potassium Tablets Recalled Due to Impurity Detection

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 100 mg, due to the presence of the impurity N-Methylnitrosobutyric acid (NMBA).

    Product
    Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-579-54
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1051-2019·2019-03-27

    Preferred Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Preferred Pharmaceuticals is recalling Losartan Potassium 50 mg tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1049-2019·2019-03-27

    Losartan Potassium Tablets Recalled Due to Impurity Presence

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 50 mg, due to the presence of an impurity, N-Methylnitrosobutyric acid (NMBA).

    Product
    Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1044-2019·2019-03-27

    AvKARE Recalls Losartan Potassium Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium Tablets 50 mg because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1013-2019·2019-03-27

    Mylan Recalls Alprazolam Tablets Due to Elevated Impurity Levels

    Mylan Institutional, Inc. is recalling specific lots of Alprazolam Tablets, 0.25 mg, because elevated levels of a known impurity were detected during stability testing.

    Product
    Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1046-2019·2019-03-27

    AvKARE Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1045-2019·2019-03-27

    AvKARE Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1047-2019·2019-03-27

    Valsartan Tablets Recalled Due to Carcinogenic Impurity

    American Health Packaging is recalling Valsartan Tablets 160 mg because a carcinogenic impurity was detected in the active ingredient.

    Product
    Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0505-2019·2019-02-27

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0504-2019·2019-02-27

    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 the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2019·2019-02-27

    Lupin Recalls Lovastatin Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Lovastatin 40 mg tablets because the drug substance used was out of specification for impurity results.

    Product
    LOVASTATIN — LOVASTATIN (LOVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0428-2019·2019-02-06

    Mylan Recalls Fexofenadine Tablets Due to Elevated Impurities

    Mylan Pharmaceuticals is recalling specific lots of Fexofenadine HCl 180 mg tablets because routine stability testing showed slightly elevated related compounds.

    Product
    Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0328-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0326-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA). The product was distributed throughout the United States.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0311-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states