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.

151–175 of 458

  • ModerateFDA (Drugs)·D-0153-2021·2020-12-23

    Taro Recalls Kaiser Permanente Clotrimazole Cream Due to Impurity

    Taro Pharmaceuticals is recalling specific lots of Kaiser Permanente Clotrimazole Cream USP 1% because an unknown degradation impurity was detected slightly above the specification limit.

    Product
    Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T1C1 Distributed by Kaiser Foundation Hospitals Livemore, CA 94551-9756. Made in Canada. NDC 0179-8014-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0154-2021·2020-12-23

    Taro Recalls Kroger Clotrimazole Cream Due to Impurity

    Taro Pharmaceuticals is recalling Kroger Athlete's Foot Cream because an unknown degradation impurity was detected slightly above the specification limit.

    Product
    KROGER — KROGER (CLOTRIMAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0158-2021·2020-12-23

    Taro Recalls TopCare Clotrimazole Cream Due to Impurity

    Taro Pharmaceuticals is recalling TopCare Clotrimazole Cream because an unknown degradation impurity was detected slightly above the specification limit.

    Product
    TOPCARE — TOPCARE (CLOTRIMAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0159-2021·2020-12-23

    Taro Recalls Clotrimazole Cream Due to Unknown Degradation Impurity

    Taro Pharmaceuticals is recalling specific lots of Clotrimazole Cream USP 1% because an unknown degradation impurity was detected slightly above the specification limit.

    Product
    Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10531. Made in Canada. UPC 3 51672 20022 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0156-2021·2020-12-23

    Taro Recalls Rite Aid Clotrimazole Cream Due to Impurity

    Taro Pharmaceuticals is recalling Rite Aid Clotrimazole Cream because an unknown degradation impurity was detected slightly above the specification limit.

    Product
    RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0151-2021·2020-12-23

    Taro Recalls Clotrimazole Cream Due to Unknown Impurity

    Taro Pharmaceuticals is recalling Equate Athlete's Foot cream because an unknown impurity was detected above specification limits.

    Product
    CLOTRIMAZOLE — CLOTRIMAZOLE (CLOTRIMAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0157-2021·2020-12-23

    Taro Recalls Clotrimazole Cream Due to Unknown Degradation Impurity

    Taro Pharmaceuticals is recalling Best Choice Clotrimazole Cream USP 1% because an unknown degradation impurity was detected slightly above the specification limit.

    Product
    Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed by: Valu Merchandisers, CO . 5000 Kansas Ave. Kansas City, KS 66106 Made in Canada. UPC 0-70038-20355-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0152-2021·2020-12-23

    Taro Recalls HEB Clotrimazole Cream Due to Impurity

    Taro Pharmaceuticals is recalling HEB Clotrimazole Cream 1% because an unknown degradation impurity was detected slightly above the specification limit.

    Product
    HEB — HEB (CLOTRIMAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0155-2021·2020-12-23

    Taro Recalls Kroger Clotrimazole Cream Due to Impurity

    Taro Pharmaceuticals is recalling Kroger Clotrimazole Cream 1% because an unknown degradation impurity was detected slightly above the specification limit.

    Product
    KROGER — KROGER (CLOTRIMAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0108-2021·2020-12-02

    Heritage Pharmaceuticals Recalls Felodipine Extended Release Tablets Due to Impurities

    Heritage Pharmaceuticals is recalling specific bottles of Felodipine Extended Release Tablets because routine testing found out-of-specification impurities.

    Product
    Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0064-2021·2020-11-11

    Teligent Pharma Recalls Fluocinonide Ointment Due to Impurity

    Teligent Pharma is recalling Fluocinonide Ointment USP 0.05% due to out-of-specification impurity results.

    Product
    Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0049-2021·2020-10-28

    Mylan Recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets Due to Impurity

    Mylan Pharmaceuticals is recalling specific lots of Candesartan Cilexetil and Hydrochlorothiazide tablets due to out-of-specification organic impurities found during routine stability testing.

    Product
    CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE — CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0018-2021·2020-10-14

    Direct Rx Recalls Losartan Potassium 100 mg Tablets Due to Impurity

    Direct Rx is recalling 33 bottles of Losartan Potassium 100 mg tablets found to contain an impurity above acceptable levels.

    Product
    Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0019-2021·2020-10-14

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity

    VistaPharm is recalling Nystatin Oral Suspension because one lot failed impurity specifications. The affected product was distributed nationwide.

    Product
    NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0032-2021·2020-10-07

    Losartan Pot/HCTZ 50/12.5 mg Recalled Due to Impurity Detection

    Direct Rx is recalling 33 bottles of Losartan Pot/HCTZ 50/12.5 mg tablets distributed in Florida due to trace amounts of impurity NMBA.

    Product
    Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1502-2020·2020-08-19

    Lupin Recalls Mibelas 24 Fe Tablets Due to Impurity Test Failures

    Lupin Pharmaceuticals is recalling Mibelas 24 Fe chewable tablets because they failed impurity specifications. The recall covers 560,922 pouches distributed nationwide.

    Product
    Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1445-2020·2020-08-05

    Sun Pharmaceutical Recalls Clonazepam Tablets Due to Cross-Contamination

    Sun Pharmaceutical is recalling Clonazepam Orally Disintegrating Tablets because routine stability testing detected cross-contamination with clozapine.

    Product
    Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1377-2020·2020-07-15

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Peak

    VistaPharm is recalling Nystatin Oral Suspension cups because an impurity peak exceeded approved specifications. The recall covers 380,700 cups distributed in the United States and Puerto Rico.

    Product
    Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1378-2020·2020-07-15

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Exceeding Specifications

    VistaPharm is recalling Nystatin Oral Suspension because an impurity peak exceeded approved specifications. The affected product is distributed in the United States and Puerto Rico.

    Product
    Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1315-2020·2020-06-24

    Aurobindo Recalls Olanzapine Tablets Due to Failed Impurity Specifications

    Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 7.5 mg, because the product failed impurity and degradation specifications.

    Product
    Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1282-2020·2020-05-27

    West-Ward Recalls Ethacrynic Acid Tablets for Impurity Failures

    West-Ward Columbus Inc is recalling Ethacrynic Acid Tablets USP, 25 mg, because the product failed impurity and degradation specifications.

    Product
    Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1272-2020·2020-05-27

    InvaGen Recalls Gabapentin Tablets Due to Impurity Test Failure

    InvaGen Pharmaceuticals is recalling 2,202 bottles of Gabapentin 600 mg tablets because they failed an impurity test during stability testing.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1103-2020·2020-04-15

    Avet Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Avet Pharmaceuticals 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 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., E
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1104-2020·2020-04-15

    Avet Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Avet Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutica
    Category
    Drug
    Distribution
    Distributed nationwide