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.

126–150 of 191

  • LowFDA (Drugs)·D-0678-2017·2017-05-03

    Novartis Recalls Isopto Carpine Eye Drops for Impurity Failures

    Novartis Pharmaceuticals is recalling specific lots of Isopto Carpine eye drops due to failed impurities and degradation specifications.

    Product
    Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0610-2017·2017-03-29

    AvKARE Recalls Famciclovir Tablets Due to Impurity Levels

    AvKARE Inc. is recalling 116 cartons of 500 mg Famciclovir tablets because the product exceeded specifications for unknown impurities.

    Product
    Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0517-2017·2017-03-22

    Teva Recalls Buprenorphine and Naloxone Sublingual Tablets Due to Impurities

    Teva Pharmaceuticals is recalling specific lots of Buprenorphine and Naloxone Sublingual Tablets because they failed impurity and degradation specifications.

    Product
    Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2017·2017-03-08

    Cyclosporine Capsules Recalled for Impurity Specification Failures

    Amerisource Health Services is recalling 454 cartons of Cyclosporine Capsules, 100 mg, due to failed impurity specifications.

    Product
    CYCLOSPORINE — CYCLOSPORINE (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2017·2017-02-08

    Fresenius Kabi Recalls Midazolam Injection Due to Impurities

    Fresenius Kabi is recalling specific lots of Midazolam Injection because they failed impurities and degradation specifications.

    Product
    MIDAZOLAM — MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0439-2017·2017-02-01

    Actavis Recalls Albuterol Sulfate Inhalation Solution Due to Impurities

    Actavis Inc is recalling specific lots of Albuterol Sulfate Inhalation Solution because the product failed impurity specifications for a known degradant.

    Product
    Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0151-2017·2016-11-30

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules because of out-of-specification results for a known compound.

    Product
    Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0111-2017·2016-10-26

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling specific lots of Paricalcitol Capsules because stability testing revealed out-of-specification impurities.

    Product
    PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0109-2017·2016-10-26

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 32,015 bottles of Paricalcitol Capsules, 1 mcg, because stability testing revealed out-of-specification impurities.

    Product
    PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0110-2017·2016-10-26

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 5,556 bottles of Paricalcitol Capsules because stability testing revealed out-of-specification impurities.

    Product
    PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0009-2017·2016-10-19

    Amerisource Health Services Recalls Paricalcitol Capsules Due to Impurities

    Amerisource Health Services is recalling 648 cartons of Paricalcitol Capsules, 1 mcg, due to failed impurities specifications.

    Product
    Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1507-2016·2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Carvediol Tablets, USP, 25 mg, because the product failed impurities and degradation specifications.

    Product
    Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by: Sun Pharmaceutical I
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1505-2016·2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Specifications

    Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets, USP, 6.25 mg, because they failed impurities and degradation specifications.

    Product
    Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle (NDC 57664-244-13), 1000-count bottle (NDC 57664-244-18), Rx Only, Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1472-2016·2016-08-31

    Actavis Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities

    Actavis Inc. is recalling 2,543 bottles of Hydrocortisone and acetic acid otic solution because stability testing showed out-of-specification results for a related compound.

    Product
    Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1035-2016·2016-06-22

    Valeant Recalls Chlordiazepoxide HCl/Clidinium Bromide Capsules Due to Impurities

    Valeant Pharmaceuticals is recalling specific lots of Chlordiazepoxide HCl/Clidinium Bromide capsules because they failed impurities and degradation specifications.

    Product
    Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North A
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0866-2016·2016-06-01

    Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

    Fresenius Kabi is recalling specific lots of Octreotide Acetate Injection because they failed impurities and degradation specifications.

    Product
    OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0867-2016·2016-06-01

    Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

    Fresenius Kabi USA is recalling Octreotide Acetate Injection vials because they failed impurities and degradation specifications.

    Product
    OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0841-2016·2016-05-18

    Dr. Reddy's Recalls Ondansetron Tablets Due to Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling 50,280 bottles of Ondansetron Tablets USP, 4 mg, due to failed impurities and degradation specifications.

    Product
    Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0826-2016·2016-04-27

    Impax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications

    Impax Laboratories is recalling specific lots of Dextroamphetamine Sulfate Tablets because they failed impurity and degradation specifications.

    Product
    Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0825-2016·2016-04-27

    Impax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications

    Impax Laboratories is recalling 67,428 bottles of Dextroamphetamine Sulfate Tablets USP, 10 mg, because the product failed impurities and degradation specifications.

    Product
    Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0814-2016·2016-04-13

    Actavis Recalls Dextroamphetamine Tablets Due to Impurity Failures

    Actavis Elizabeth LLC is recalling 257,746 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, because they failed impurity specifications.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 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
  • SevereFDA (Drugs)·D-0816-2016·2016-04-13

    Actavis Recalls Amphetamine Tablets Due to Impurity Failures

    Actavis is recalling specific lots of amphetamine tablets because they failed impurity specifications. Consumers should stop using the product and contact their pharmacist.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 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, Mo
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0813-2016·2016-04-13

    Actavis Recalls Dextroamphetamine Tablets for Impurity Failures

    Actavis is recalling specific lots of 10 mg dextroamphetamine tablets because they failed impurity specifications. The recall covers 114,388 bottles distributed nationwide.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 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