The Recall Desk

Hazard

Impurities recalls

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

What the numbers show

Total
191
Critical
4
Severe
23
Most recent
2026-08-05

Of the 191 impurities recalls we have scored against our rubric, 4 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 23 (12%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all impurities 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.

176–191 of 191

  • ModerateFDA (Drugs)·D-1187-2014·2014-04-09

    Lupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failure

    Lupin Pharmaceuticals is recalling specific lots 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, 20 mL (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 27437-207-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1075-2014·2014-02-12

    Teva Recalls Hydralazine HCL Tablets Due to Impurity Concerns

    Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 50 mg tablets because they may fail impurity specifications throughout their shelf life.

    Product
    Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (single
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1074-2014·2014-02-12

    Teva Recalls Hydralazine HCL Tablets Due to Impurity Concerns

    Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 25 mg tablets because they may contain impurities outside of specification limits.

    Product
    Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister).
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-822-2013·2013-08-07

    Warner Chilcott Recalls Enablex Extended Release Tablets Due to Impurities

    Warner Chilcott US LLC is recalling 188,600 bottles of Enablex (darifenacin) 15 mg extended-release tablets because they failed impurity specifications.

    Product
    Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-688-2013·2013-07-17

    Fresenius Kabi Recalls Folic Acid Injection Due to Impurities

    Fresenius Kabi USA is recalling 80,480 vials of Folic Acid Injection due to failed impurities and degradation specifications.

    Product
    Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-599-2013·2013-06-19

    Actavis Recalls Fentanyl Transdermal Systems Due to Impurity Specifications

    Actavis is recalling Fentanyl Transdermal Systems, 50 mcg/h, because they failed impurities and degradation specifications.

    Product
    Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-156-2013·2013-02-13

    Bayer Recalls Leukine Sargramostim Vials Due to Impurities

    Bayer HealthCare Pharmaceuticals is recalling Leukine sargramostim vials because a confirmed out-of-specification result for impurities was found in one lot.

    Product
    Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-094-2013·2012-12-26

    Watson Recalls Caziant Tablets Due to Out-of-Specification Impurities

    Watson Laboratories is recalling Caziant tablets because out-of-specification results were obtained for a known impurity.

    Product
    Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Wa
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-068-2013·2012-12-05

    GlaxoSmithKline Recalls Arranon Injection Due to Potential Impurities

    GlaxoSmithKline is recalling specific lots of Arranon (nelarabine) Injection because drug-related impurities may exceed specification limits.

    Product
    Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-006-2013·2012-10-17

    Actavis Recalls Prometh VC with Codeine Cough Syrup Due to Stability Issues

    Actavis Mid Atlantic LLC is recalling Prometh VC with Codeine Cough Syrup because specific lots do not meet room temperature stability specifications for an unknown degradant.

    Product
    Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-005-2013·2012-10-17

    Actavis Recalls Prometh VC Plain Due to Unknown Degradant

    Actavis Mid Atlantic LLC is recalling Prometh VC Plain bottles because they do not meet stability specifications for an unknown degradant.

    Product
    Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1703-2012·2012-10-10

    Mylan Recalls Famotidine Tablets Due to Out-of-Specification Impurities

    Mylan Pharmaceuticals is recalling 31,867 bottles of Famotidine Tablets USP, 20 mg, due to out-of-specification results for related compounds found during routine stability testing.

    Product
    Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1436-2012·2012-08-08

    Watson Recalls Caziant Tablets Due to High Impurity Levels

    Watson Laboratories is recalling Caziant tablets because high levels of impurities were detected. Consumers should stop using the product and contact their healthcare provider.

    Product
    Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Wa
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1416-2012·2012-07-18

    VistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Impurities

    VistaPharm is recalling specific lots of Hydrocodone Bitartrate & Acetaminophen Oral Solution because impurities exceeded specifications during stability testing.

    Product
    Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1411-2012·2012-07-18

    Qualitest Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities

    Vintage Pharmaceuticals is recalling 54,431 bottles of Hydrocortisone and Acetic Acid Otic Solution because impurity levels exceeded specifications.

    Product
    HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
    Category
    Drug
    Distribution
    Distributed nationwide