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.

401–425 of 458

  • ModerateFDA (Drugs)·D-0288-2015·2014-12-10

    Sandoz Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Sandoz, Inc. is recalling 6,336 bottles of 16 mg candesartan cilexetil tablets because stability testing showed impurity levels exceeded specifications.

    Product
    candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0246-2015·2014-11-19

    Micro Labs Recalls Simvastatin Tablets Due to Impurity Specification Failure

    Micro Labs USA Inc. is recalling 1,008 bottles of Simvastatin Tablets, 10 mg, because the product failed impurity content specifications.

    Product
    Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0247-2015·2014-11-19

    Fresenius Kabi Recalls Haloperidol Decanoate Injection Due to Impurity Failure

    Fresenius Kabi is recalling Haloperidol Decanoate Injection vials due to an out-of-specification impurity result. The recall covers 216,517 vials distributed nationwide and in Puerto Rico.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0240-2015·2014-11-12

    Pharmaceutical Associates Recalls Cyproheptadine HCl Syrup Due to Impurity

    Pharmaceutical Associates Inc. is recalling 9,640 unit dose cups of Cyproheptadine HCl Syrup because an unidentified impurity exceeded specifications during stability testing.

    Product
    Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0235-2015·2014-11-12

    Pfizer Recalls TORISEL Kits Due to Diluent Crystallization

    Pfizer is recalling 16,000 TORISEL kits because impurities in the diluent may cause crystals to form after cold storage. The TORISEL drug vials are not affected.

    Product
    TORISEL — TORISEL (TEMSIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0243-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 16 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0244-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 32 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0242-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling specific lots of Candesartan Cilexetil Tablets because they failed impurity and degradation specifications.

    Product
    Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0050-2015·2014-11-05

    Teva Recalls Dextroamphetamine Tablets Due to Unknown Impurities

    Teva Pharmaceuticals is recalling specific lots of dextroamphetamine tablets because they failed impurity specifications. The recall covers 19,545 bottles distributed nationwide.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0048-2015·2014-11-05

    Hi-Tech Pharmacal Recalls HydrOXYzine Hydrochloride Oral Solution Due to Impurity

    Hi-Tech Pharmacal Co., Inc. is recalling 451,916 bottles of HydrOXYzine Hydrochloride Oral Solution because an unknown impurity exceeded specifications during stability testing.

    Product
    HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1571-2014·2014-10-01

    Akorn Recalls Rifampin for Injection Due to Impurity Specification Failure

    Akorn, Inc. is recalling 5,539 vials of Rifampin for Injection USP, 600 mg, because a stability test showed an impurity level exceeding specifications.

    Product
    Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1604-2014·2014-10-01

    Hospira Recalls Buprenorphine Hydrochloride Injection Due to Impurity Failure

    Hospira Inc. is recalling specific lots of Buprenorphine Hydrochloride Injection because the product failed impurity specifications during stability testing.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1570-2014·2014-09-24

    Apotex Recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets Due to Impurity

    Apotex Corp. is recalling Candesartan Cilexetil and Hydrochlorothiazide Tablets because a specific degradant exceeded safety specifications.

    Product
    Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1484-2014·2014-09-03

    Novel Laboratories Recalls Famotidine Oral Suspension Due to Impurity Failure

    Novel Laboratories is recalling 25,776 containers of Famotidine Oral Suspension because the product failed an impurity specification. The recall is classified as FDA Class III.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1539-2014·2014-08-27

    Mylan Recalls Tolterodine Tartrate Tablets Due to Impurity Failures

    Mylan Pharmaceuticals is recalling 9,225 bottles of Tolterodine Tartrate Tablets, 1 mg, because the product failed impurity specifications for lactol and total impurities.

    Product
    Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1513-2014·2014-08-13

    Wockhardt Recalls BuPROPion HCl Extended-Release Tablets Due to Impurity Levels

    Wockhardt USA is recalling 840 bottles of buPROPion HCl Extended-Release Tablets because out-of-specification levels of the impurity m-chlorobenzoic acid were observed.

    Product
    buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1437-2014·2014-07-23

    Teva Recalls Mircette Tablets Due to Out-of-Specification Impurities

    Teva Pharmaceuticals is recalling Mircette tablets because impurity test results were out of specification. The recall covers 984 blister packs distributed nationwide.

    Product
    Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1439-2014·2014-07-23

    Teva Recalls Velivet Birth Control Pills Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 5,265 blister packs of Velivet birth control pills nationwide because impurity test results were out of specification.

    Product
    VELIVET — VELIVET (DESOGESTREL AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1324-2014·2014-05-28

    Teva Recalls Buprenorphine Hydrochloride Sublingual Tablets Due to Impurity Failures

    Teva Pharmaceuticals is recalling 17,181 bottles of 2 mg Buprenorphine Hydrochloride Sublingual Tablets because stability testing revealed high out-of-specification impurity levels.

    Product
    BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1325-2014·2014-05-28

    Teva Recalls Buprenorphine Hydrochloride Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 53,452 bottles of 8 mg Buprenorphine Hydrochloride sublingual tablets because stability testing revealed high out-of-specification impurity levels.

    Product
    BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1297-2014·2014-05-07

    Caraco Recalls Children's Cetirizine Tablets Due to Impurity Failures

    Caraco Pharmaceutical Laboratories is recalling 47,813 bottles of Children's Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing for N-Oxide.

    Product
    Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1299-2014·2014-05-07

    Apotex Recalls Risperidone Oral Solution Due to Impurity Specification Failure

    Apotex Inc. is recalling Risperidone Oral Solution because it failed impurity specifications at the 18-month stability time point.

    Product
    Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
    Category
    Drug
    Distribution
    Distributed nationwide