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.

351–375 of 458

  • LowFDA (Drugs)·D-0438-2017·2017-02-01

    Qualitest Recalls Dexamethasone Elixir Due to Failed Impurity Specifications

    Vintage Pharmaceuticals is recalling 2,568 bottles of Dexamethasone Elixir because the product failed impurity and degradation specifications.

    Product
    DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0424-2017·2017-01-18

    Pfizer Recalls Cytotec Tablets Due to Failed Impurity Specifications

    Pfizer is recalling 1,706 cartons of Cytotec (misoprostol) tablets nationwide because the product failed impurity and degradation specifications.

    Product
    CYTOTEC — CYTOTEC (MISOPROSTOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0135-2017·2016-11-16

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional, Inc. is recalling specific lots of Clonazepam Tablets, USP, 0.5 mg because they failed impurity specifications.

    Product
    Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0136-2017·2016-11-16

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional is recalling specific lots of Clonazepam 1.0 mg tablets because a known impurity exceeded specification limits during stability testing.

    Product
    Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0095-2017·2016-10-19

    Teva Recalls MitoXANTRONE Injection Due to Potential Impurity D Failure

    Teva Pharmaceuticals USA is recalling MitoXANTRONE Injection USP vials nationwide because they may fail to meet specifications for Impurity D throughout their shelf life.

    Product
    mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1491-2016·2016-09-14

    Zydus Recalls Bromocriptine Mesylate Capsules Due to Stability Test Failures

    Zydus Pharmaceuticals is recalling 14,808 bottles of Bromocriptine Mesylate 5 mg capsules because stability samples failed impurity tests.

    Product
    BROMOCRIPTINE MESYLATE — BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1469-2016·2016-08-31

    Akorn Recalls Desoximetasone Gel Due to Impurity Specification Failure

    Akorn, Inc. is recalling Desoximetasone Gel USP, 0.05%, because the product failed impurity specifications at the 9-month stability time point.

    Product
    Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1471-2016·2016-08-31

    Actavis Recalls Acetasol HC Otic Solution Due to Impurity Failure

    Actavis Inc is recalling 672 bottles of Acetasol HC otic solution because stability testing showed an out-of-specification related compound at the 12-month time point.

    Product
    Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1451-2016·2016-08-03

    Teva Recalls MitoXANTRONE Injection Due to High Impurity Levels

    Teva North America is recalling 2,506 vials of MitoXANTRONE Injection USP because high levels of Impurity D were detected.

    Product
    mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1441-2016·2016-07-20

    West-Ward Recalls Oxycodone Hydrochloride Oral Solution for Impurity Failures

    West-Ward Columbus Inc. is recalling 1,182 bottles of Oxycodone Hydrochloride Oral Solution due to failed impurities and degradation specifications.

    Product
    OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1063-2016·2016-07-13

    Dr. Reddy's Recalls Sirolimus Tablets Due to Impurity

    Dr. Reddy's Laboratories is recalling specific lots of Sirolimus tablets because they failed impurity specifications for secorapamycin.

    Product
    SIROLIMUS — SIROLIMUS (SIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1060-2016·2016-07-06

    Actavis Recalls Ciprofloxacin Ophthalmic Solution Due to Impurity

    Actavis Pharma Inc. is voluntarily recalling Ciprofloxacin Ophthalmic Solution due to out-of-specification results for an unknown impurity near expiration.

    Product
    Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1061-2016·2016-07-06

    Aidarex Recalls Ciprofloxacin Ophthalmic Solution Due to Unknown Impurity

    Aidarex Pharmaceuticals is recalling 599 bottles of Ciprofloxacin Ophthalmic Solution because testing revealed out-of-specification results for an unknown impurity.

    Product
    Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1058-2016·2016-07-06

    CVS Acid Controller Tablets Recalled for Impurity Specification Failure

    Dr. Reddy's is recalling CVS pharmacy Acid Controller tablets because stability testing revealed an out-of-specification impurity.

    Product
    CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1046-2016·2016-06-29

    Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Test Failure

    Sandoz, Inc. is recalling specific lots of Dicloxacillin Sodium Capsules, 500mg, because testing revealed an out-of-specification result for a known impurity.

    Product
    Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1045-2016·2016-06-29

    Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Testing Failures

    Sandoz, Inc. is recalling Dicloxacillin Sodium Capsules because testing revealed out-of-specification results for a known impurity.

    Product
    Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1038-2016·2016-06-22

    Par Pharmaceutical Recalls Pramipexole Dihydrochloride Extended Release Tablets

    Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because they contain a known impurity above approved specification levels.

    Product
    Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1034-2016·2016-06-22

    Valeant Recalls Librax Capsules Due to Failed Impurity Specifications

    Valeant Pharmaceuticals is recalling specific lots of Librax capsules because they failed impurity and degradation specifications.

    Product
    LIBRAX — LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0975-2016·2016-06-15

    Aidarex Recalls Chlorhexidine Gluconate Oral Rinse Due to Impurity

    Aidarex Pharmaceuticals is recalling 292 bottles of Chlorhexidine Gluconate 0.12% Oral Rinse because the product failed impurity specifications.

    Product
    CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0876-2016·2016-06-01

    Akorn Recalls PerioRx Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling PerioRx oral rinse because multiple batches failed impurity specifications. The product contains an unknown impurity of chlorhexidine gluconate.

    Product
    PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0874-2016·2016-06-01

    Akorn Recalls ORIS Chlorhexidine Oral Rinse Due to Impurity

    Akorn, Inc. is recalling ORIS (chlorhexidine gluconate) oral rinse because multiple batches failed impurity specifications.

    Product
    ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0875-2016·2016-06-01

    Akorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling Chlorhexidine gluconate oral rinse due to an out-of-specification result for an unknown impurity.

    Product
    Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0818-2016·2016-04-20

    Fresenius Kabi Recalls Haloperidol Decanoate Injection Due to Impurity

    Fresenius Kabi USA, LLC is recalling Haloperidol Decanoate Injection due to an impurity out-of-specification result. The recall affects 48,210 units distributed nationwide and in Puerto Rico.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0809-2016·2016-04-13

    Bio-pharm Recalls Ranitidine Syrup Due to Elevated Impurity Levels

    Bio-pharm, Inc. is recalling Ranitidine Syrup because routine stability testing detected elevated impurity levels.

    Product
    Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0770-2016·2016-03-16

    FDA Recalls Atorvastatin Calcium 80 mg Due to Impurity Failures

    Golden State Medical Supply Inc. is recalling specific lots of Atorvastatin Calcium 80 mg tablets because they failed impurity and degradation specifications.

    Product
    Atorvastatin Calcium 80 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 # 60429-326-77
    Category
    Drug
    Distribution
    Distributed nationwide