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.

151–175 of 191

  • SevereFDA (Drugs)·D-0774-2016·2016-03-23

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling Paricalcitol Capsules because stability testing revealed out-of-specification impurities. The recall covers 30,891 bottles distributed nationwide and in Puerto Rico.

    Product
    Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0767-2016·2016-03-16

    Golden State Medical Supply Recalls Atorvastatin Calcium 10 mg Tablets

    Golden State Medical Supply Inc. is recalling specific lots of Atorvastatin Calcium 10 mg tablets due to failed impurities and degradation specifications.

    Product
    Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0769-2016·2016-03-16

    Atorvastatin Calcium 40 mg Recalled for Impurity Failures

    Golden State Medical Supply Inc. is recalling Atorvastatin Calcium 40 mg tablets due to failed impurities and degradation specifications.

    Product
    Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0768-2016·2016-03-16

    Golden State Medical Supply Recalls Atorvastatin Calcium 20 mg Tablets

    Golden State Medical Supply is recalling specific lots of Atorvastatin Calcium 20 mg tablets due to failed impurities and degradation specifications.

    Product
    Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-324-77
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0660-2016·2016-02-17

    Amerisource Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Amerisource Health Services is recalling 716 cartons of Candesartan Cilexetil Tablets, 16 mg, due to failed impurities and degradation specifications.

    Product
    Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0563-2016·2016-01-13

    Avantor Recalls Magnesium Sulfate 7-Hydrate Due to Impurity Failures

    Avantor Performance Materials is recalling 265 drums of Magnesium Sulfate 7-Hydrate for parenteral use because the product failed impurity specifications.

    Product
    Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0509-2016·2015-12-16

    Golden State Medical Supply Recalls Meclizine Hydrochloride Tablets Due to Impurities

    Golden State Medical Supply Inc. is recalling 1,136 bottles of Meclizine Hydrochloride tablets because they failed impurity specifications.

    Product
    MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0510-2016·2015-12-16

    Golden State Medical Supply Recalls Meclizine Hydrochloride Tablets for Impurities

    Golden State Medical Supply Inc. is recalling Meclizine Hydrochloride 25 mg tablets because they failed impurity specifications.

    Product
    MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0234-2016·2015-11-25

    Par Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures

    Par Pharmaceutical is recalling Meclizine Hydrochloride Tablets because they failed impurity specifications. The recall covers 100 and 1000-count bottles distributed nationwide.

    Product
    Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0233-2016·2015-11-25

    Par Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurities

    Par Pharmaceutical is recalling specific lots of Meclizine Hydrochloride 12.5 mg tablets because they failed impurity specifications.

    Product
    Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0054-2016·2015-10-28

    Hospira Recalls Amidate Etomidate Injection Due to Degradation Impurities

    Hospira Inc. is recalling 24,100 syringes of Amidate (Etomidate Injection) because stability testing confirmed out-of-specification degradation products.

    Product
    Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1139-2015·2015-06-24

    West-Ward Recalls Fentanyl Citrate Injection Due to Impurity Failures

    West-Ward Pharmaceutical Corp. is recalling Fentanyl Citrate Injection due to failed impurities and degradation specifications. The recall covers 14,649 cartons distributed nationwide.

    Product
    FENTANYL CITRATE — FENTANYL CITRATE (FENTANYL CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1130-2015·2015-06-17

    Akorn Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurities

    Akorn, Inc. is recalling Hydroxyzine Hydrochloride oral solution because it failed impurities and degradation specifications. The product was distributed nationwide, including Puerto Rico.

    Product
    Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1129-2015·2015-06-17

    Akorn Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurity Failures

    Akorn, Inc. is recalling 424,174 bottles of Hydroxyzine Hydrochloride oral solution because the product failed impurities and degradation specifications.

    Product
    Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0433-2015·2015-04-15

    Hospira Recalls MitoXANTRONE Injection Due to Stability Failures

    Hospira Inc. is recalling MitoXANTRONE Injection vials because the product failed stability specifications, resulting in subpotent medication and out-of-specification impurities.

    Product
    MITOXANTRONE — MITOXANTRONE (MITOXANTRONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0414-2015·2015-03-25

    Mutual Pharmaceutical Recalls Ergoloid Mesylates Tablets Due to Impurities

    Mutual Pharmaceutical is recalling Ergoloid Mesylates 1 mg tablets because they failed impurity and degradation specifications during stability testing.

    Product
    Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0413-2015·2015-03-25

    Mylan Recalls Subpotent Nicardipine Hydrochloride Injection Vials

    Mylan Institutional LLC is recalling specific lots of Nicardipine Hydrochloride Injection because the product failed potency and impurity specifications.

    Product
    Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0404-2015·2015-03-11

    Pfizer Recalls Oxecta Tablets Due to Failed Impurity Specifications

    Pfizer is recalling 139 bottles of Oxecta (oxycodone HCl) 7.5 mg tablets because they failed impurity and degradation specifications.

    Product
    Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0403-2015·2015-03-11

    Pfizer Recalls Oxecta Tablets Due to Failed Impurity Specifications

    Pfizer is recalling 137 bottles of Oxecta (oxycodone HCl) 5 mg tablets because they failed impurity and degradation specifications.

    Product
    Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0241-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 4 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1557-2014·2014-09-03

    Mylan Recalls Diltiazem HCl Extended Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended Release Capsules because routine stability testing found high levels of a related compound.

    Product
    Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1499-2014·2014-08-06

    Teva Recalls Lansoprazole Triple Therapy Blister Packs Due to Impurities

    Teva Pharmaceuticals is recalling 89,215 blister packs of triple therapy containing lansoprazole, clarithromycin, and amoxicillin due to failed impurity specifications.

    Product
    triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxici
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1435-2014·2014-07-23

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Institutional, Inc. is recalling Diltiazem HCl Extended-Release Capsules, 120 mg, due to high out-of-specification results for a related compound found during routine stability testing.

    Product
    Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1408-2014·2014-07-02

    Teva Recalls Dextroamphetamine Sulfate Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 9,882 bottles of Dextroamphetamine Sulfate 10 mg tablets because stability testing revealed out-of-specification impurities.

    Product
    DEXTROAMPHETAMINE SULFATE — DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1296-2014·2014-05-07

    Caraco Recalls Cetirizine Hydrochloride Chewable Tablets Due to Impurities

    Caraco Pharmaceutical Laboratories is recalling specific lots of Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing.

    Product
    Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
    Category
    Drug
    Distribution
    Distributed nationwide