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.

326–350 of 458

  • LowFDA (Drugs)·D-0051-2018·2017-11-01

    Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures

    Wockhardt USA is recalling 5mg Enalapril Maleate tablets because they failed impurity specifications. The recall covers 5,050 bottles distributed nationwide.

    Product
    Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0013-2018·2017-10-25

    Alprazolam Tablets Recalled for Unknown Impurity

    The Harvard Drug Group is recalling Alprazolam Tablets, 0.25 mg, due to an out-of-specification result for an unknown impurity.

    Product
    Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laure
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0010-2018·2017-10-25

    Unichem Recalls Bisoprolol Fumarate Tablets Due to Stability Impurity

    Unichem Pharmaceuticals is recalling 96,876 bottles of Bisoprolol Fumarate 5 mg tablets because stability testing revealed an out-of-specification unknown impurity.

    Product
    BISOPROLOL FUMARATE — BISOPROLOL FUMARATE (BISOPROLOL FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0009-2018·2017-10-18

    Dr. Reddy's Recalls Famotidine Tablets Due to Impurity Failure

    Dr. Reddy's is recalling specific lots of famotidine tablets sold as CVS Pharmacy Acid Controller and Equate Famotidine due to an out-of-specification impurity result.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0001-2018·2017-10-11

    Pfizer Recalls Deferoxamine Mesylate Injection Due to CGMP Deviations

    Pfizer is recalling 32,276 vials of Deferoxamine Mesylate for injection due to a failure to control impurities causing color change at the API stage.

    Product
    Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1162-2017·2017-09-20

    Aidarex Recalls Phentermine Capsules Due to Impurity Test Failures

    Aidarex Pharmaceuticals is recalling 35 bottles of Phentermine 15 mg capsules because they failed impurity specifications during stability testing.

    Product
    Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1094-2017·2017-08-23

    AvKARE Recalls Voriconazole Tablets Due to Impurity Specification Failure

    AvKARE Inc. is recalling specific lots of Voriconazole Tablets, 200 mg, because they failed impurity specifications for a related compound.

    Product
    Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1083-2017·2017-08-23

    KVK-Tech Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    KVK-Tech, Inc. is recalling specific lots of Phentermine Hydrochloride capsules because they failed impurity specifications during stability testing.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1038-2017·2017-08-09

    Dr. Reddy's Recalls Pravastatin Sodium Tablets Due to Impurity

    Dr. Reddy's Laboratories is recalling specific lots of Pravastatin Sodium tablets because they failed impurity specifications.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0980-2017·2017-07-26

    Hospira Recalls Argatroban Injection Due to Impurity Specification Failure

    Hospira is recalling 701 vials of Argatroban Injection because a denitroquinoline-related impurity exceeded specifications during testing.

    Product
    Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0942-2017·2017-07-12

    Lantheus Recalls Fludeoxyglucose F 18 Injection Due to Residual Solvent

    Lantheus is recalling 26 doses of Fludeoxyglucose F 18 Injection in Puerto Rico because the product failed impurity specifications for acetonitrile residual solvent.

    Product
    Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0945-2017·2017-07-12

    G & W Clobetasol Propionate Ointment Recalled for Impurity

    G & W Laboratories is recalling Clobetasol Propionate Ointment 0.05% due to out-of-specification results for a known impurity.

    Product
    CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0920-2017·2017-06-21

    Mylan Recalls Montelukast Sodium Oral Granules Due to Impurity Failures

    Mylan Pharmaceuticals is recalling 11,624 pouches of Montelukast Sodium Oral Granules, 4 mg, due to failed impurity specifications.

    Product
    Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0869-2017·2017-06-07

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity

    VistaPharm is recalling Nystatin Oral Suspension because it contains an impurity peak that exceeds approved specifications.

    Product
    Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0669-2017·2017-04-19

    Jubilant Cadista Recalls Bupropion Hydrochloride Tablets for Impurity Issues

    Jubilant Cadista Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets due to high levels of a degradation product.

    Product
    BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmace
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0671-2017·2017-04-19

    Jubilant Cadista Recalls Bupropion Hydrochloride Tablets for Impurity Failure

    Jubilant Cadista Pharmaceuticals is recalling Bupropion Hydrochloride Extended-release Tablets because high levels of a degradation product were detected.

    Product
    BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmace
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0650-2017·2017-04-12

    Lupin Recalls Quinapril Tablets Due to Impurity A Specification Failure

    Lupin Pharmaceuticals is recalling Quinapril 5 mg tablets because they failed impurity specifications. The recall covers 15,168 bottles distributed nationwide.

    Product
    QUINAPRIL — QUINAPRIL (QUINAPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2017·2017-03-15

    Actavis Recalls Levofloxacin Ophthalmic Solution Due to Impurity Failure

    Actavis Inc is recalling specific lots of Levofloxacin Ophthalmic Solution because the product failed impurity specifications for a related compound.

    Product
    Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0501-2017·2017-03-08

    G&W Laboratories Recalls Indocin Suppositories for Impurity Failures

    G&W Laboratories is recalling Indocin suppositories due to out-of-specification impurity results found during stability testing.

    Product
    Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0503-2017·2017-03-08

    Perrigo Recalls Salicylic Acid Shampoo Due to Organic Impurity

    L. Perrigo Company is recalling Salicylic Acid Shampoo, 6%, because the active ingredient failed impurity specifications.

    Product
    Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01, UPC 3 45802-237-01 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0504-2017·2017-03-08

    Perrigo Recalls Salicylic Acid Cream Due to Organic Impurity

    L. Perrigo Company is recalling Salicylic Acid Cream, 6%, due to an out-of-specification organic impurity. The FDA classified this as a Class III recall.

    Product
    Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0475-2017·2017-03-01

    Apotex Recalls Cyclosporine Capsules Due to Impurity Failures

    Apotex Inc. is recalling 19,584 bottles of Cyclosporine Capsules, USP, 100 mg, because the product failed impurity specifications.

    Product
    CYCLOSPORINE — CYCLOSPORINE (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0479-2017·2017-02-22

    Teva Recalls Mimvey Lo Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals USA is recalling specific lots of Mimvey Lo tablets because they failed impurity specifications for norethindrone.

    Product
    Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharm
    Category
    Drug
    Distribution
    Distributed nationwide