The Recall Desk

Hazard

Impurity Failure recalls

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

What the numbers show

Total
20
Critical
0
Severe
1
Most recent
2026-08-05

Of the 20 impurity failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (5%) 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 failure 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.

1–20 of 20

  • LowFDA (Drugs)·D-0737-2026·2026-08-05

    Dabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure

    Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules (150 mg) because testing showed impurities exceeded established limits during stability testing.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0443-2024·2024-04-24

    Digoxin Tablets Recalled Due to Failed Impurity and Degradation Specifications

    Novitium Pharma LLC is recalling 1,003 bottles of Digoxin tablets (Lot M23011A, expiring 12/2024) distributed nationwide due to failed impurity and degradation specifications. Patients should consult their healthcare provider immediately.

    Product
    DIGOXIN — DIGOXIN (DIGOXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0165-2023·2023-01-25

    Prescription Rifampin Capsules Recalled Due to Failed Quality Specifications

    Amerisource Health Services is recalling Rifampin Capsules USP 300 mg nationwide due to failed impurities and degradation specifications. Affected patients should contact their healthcare provider before using remaining inventory.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0652-2022·2022-03-16

    Oxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure

    American Health Packaging is recalling one lot of Oxycodone Hydrochloride Oral Solution due to impurity failure detected at initial testing of the repackaged product.

    Product
    OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0243-2021·2021-02-03

    Bausch Health Recalls Mephyton Tablets Due to Impurity D Failure

    Bausch Health is recalling 895 bottles of Mephyton (phytonadione) 5mg tablets because Impurity D failed stability testing specifications.

    Product
    Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1870-2019·2019-09-25

    Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets for Impurity Failures

    Aurolife Pharma is recalling specific lots of 180 mg Fexofenadine Hydrochloride tablets because they failed impurity and degradation specifications.

    Product
    Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1072-2019·2019-04-10

    Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures

    Pfizer is recalling specific lots of Clindamycin Injection due to high out-of-specification impurity results at the 24-month time point.

    Product
    Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1069-2019·2019-04-10

    Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures

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

    Product
    CLEOCIN PHOSPHATE — CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1068-2019·2019-04-10

    Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures

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

    Product
    CLEOCIN PHOSPHATE — CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0429-2019·2019-02-13

    Lupin Recalls Bimatoprost Ophthalmic Solution Due to Impurity Failures

    Lupin Pharmaceuticals is recalling Bimatoprost Ophthalmic Solution 0.03% because out-of-specification results were observed for individual and total impurities.

    Product
    Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0092-2019·2018-10-31

    Lupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurity Failures

    Lupin Pharmaceuticals is recalling 2,712 bottles of Fluocinolone Acetonide Topical Solution because stability testing showed total impurities exceeded specifications.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0420-2018·2018-02-07

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

    Dr. Reddy's is recalling 12,579 bottles of Atorvastatin Calcium 40 mg tablets because they failed impurity specifications during stability testing.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0005-2017·2016-10-12

    Teva Recalls Claravis Isotretinoin Capsules Due to Impurity Failures

    Teva North America is recalling Claravis (isotretinoin) capsules because they failed impurity and degradation specifications.

    Product
    Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1504-2016·2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets because they failed impurity and degradation specifications.

    Product
    Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1506-2016·2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets, 12.5 mg, because they failed impurities and degradation specifications.

    Product
    Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0815-2016·2016-04-13

    Actavis Recalls Dextroamphetamine Tablets Due to Impurity Failures

    Actavis Elizabeth LLC is recalling 182,378 bottles of 30 mg Dextroamphetamine and Amphetamine tablets because they failed impurity specifications.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0659-2016·2016-02-17

    Sandoz Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Sandoz Inc. is recalling Candesartan Cilexetil Tablets, 16 mg, because the product failed impurities and degradation specifications at a 9-month stability timepoint.

    Product
    Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0235-2016·2015-11-25

    Mylan Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures

    Mylan Institutional is recalling 4,609 packages of Meclizine Hydrochloride 25 mg tablets because they failed impurity specifications.

    Product
    Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1186-2014·2014-04-09

    Lupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failures

    Lupin Pharmaceuticals is recalling 4,038 bottles of Suprax Cefixime for Oral Suspension because the product failed impurity specifications at the 9-month stability station.

    Product
    Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-141-12013·2013-02-06

    Femtrace Tablets Recalled for Moisture Ingress and Impurity Failures

    Warner Chilcott is recalling 5,439 bottles of Femtrace 0.9 mg tablets nationwide due to moisture ingress causing failed impurity specifications.

    Product
    Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
    Category
    Drug
    Distribution
    Distributed nationwide