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.

276–300 of 458

  • SevereFDA (Drugs)·D-0318-2019·2018-12-19

    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
  • SevereFDA (Drugs)·D-0312-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0327-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Valsartan 320 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0309-2019·2018-12-19

    Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACE
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0310-2019·2018-12-19

    Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Teva Pharmaceuticals USA is recalling Amlodipine, Valsartan, and Hydrochlorothiazide Tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACE
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0325-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to Trace NDEA Impurity

    Mylan is recalling specific lots of Valsartan 80 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0307-2019·2018-12-19

    Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0306-2019·2018-12-19

    Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 10 mg/320 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0331-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0324-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling specific lots of Valsartan 40 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0359-2019·2018-12-05

    Sandoz Losartan Potassium and Hydrochlorothiazide Tablets Recalled for NDEA Impurity

    Sandoz is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1208-2019·2018-12-05

    Akorn Recalls Clindamycin Phosphate Topical Solution Due to Impurity Failures

    Akorn, Inc. is recalling 58,393 jars of Clindamycin Phosphate Topical Solution USP, 1% because the product failed impurity and degradation specifications.

    Product
    Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0271-2019·2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 150 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0263-2019·2018-11-28

    FDA Recalls Irbesartan Tablets Due to NDEA Impurity

    Golden State Medical Supply Inc. is recalling 2,439 bottles of Irbesartan 75 mg tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0265-2019·2018-11-28

    Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity

    Golden State Medical Supply is recalling 12,502 bottles of Irbesartan 300 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).

    Product
    IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0276-2019·2018-11-21

    Taro Recalls Children's Allergy Solution Due to Impurity

    Taro Pharmaceuticals is recalling 12,432 bottles of Children's 24 Hour Allergy Oral Solution because an unknown impurity exceeded limits during stability testing.

    Product
    Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0277-2019·2018-11-21

    Taro Recalls Children's Allergy Oral Solution Due to Impurity

    Taro Pharmaceuticals is recalling 8,328 bottles of Children's Allergy (cetirizine hydrochloride) oral solution because an unknown impurity exceeded specified limits during stability testing.

    Product
    CHILDRENS ALLERGY — CHILDRENS ALLERGY (CETIRIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0278-2019·2018-11-21

    Taro Recalls Children's Allergy Relief Oral Solution Due to Impurity

    Taro Pharmaceuticals is recalling specific bottles of children's allergy relief oral solution because an unknown impurity exceeded safety limits during routine testing.

    Product
    children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0286-2019·2018-11-21

    Takeda Recalls Amitiza Capsules Due to Elevated Impurity Levels

    Takeda is recalling specific lots of Amitiza (lubiprostone) capsules because stability testing found elevated levels of a known impurity.

    Product
    AMITIZA — AMITIZA (LUBIPROSTONE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0281-2019·2018-10-31

    Upsher Smith Recalls Bumetanide Tablets for Unspecified Degradation Product

    Upsher Smith Laboratories is recalling 29,080 bottles of Bumetanide 2 mg tablets because the product failed impurity specifications for an unspecified degradation product.

    Product
    BUMETANIDE — BUMETANIDE (BUMETANIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1214-2018·2018-09-26

    Lupin Recalls Morphine Sulfate Extended-Release Tablets Due to Impurity

    Lupin Pharmaceuticals is recalling specific lots of Morphine Sulfate Extended-Release Tablets because testing found an impurity exceeding safety limits.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1212-2018·2018-09-26

    InvaGen Recalls Bupropion Hydrochloride Tablets Due to Impurity Levels

    InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride ER tablets because older batches failed impurity specifications.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1185-2018·2018-09-19

    Par Pharmaceutical Recalls Pramipexole Dihydrochloride Extended Release Tablets

    Par Pharmaceutical is recalling Pramipexole dihydrochloride extended release tablets because they contain a known impurity at levels exceeding specifications.

    Product
    Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1183-2018·2018-09-12

    Akorn Recalls Ethosuximide Capsules Due to Impurity Failures

    Akorn, Inc. is recalling Ethosuximide Capsules, 250 mg, due to out-of-specification results for an unspecified impurity.

    Product
    Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01
    Category
    Drug
    Distribution
    Distributed nationwide