The Recall Desk

Hazard

Unknown Impurity recalls

8 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
8
Critical
0
Severe
1
Most recent
2024-09-04

Of the 8 unknown 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 1 (13%) 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 unknown 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.

1–8 of 8

  • HighFDA (Drugs)·D-0644-2024·2024-09-04

    Prescription Ibuprofen Recalled Due to Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.

    Product
    IBU — IBU (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0319-2024·2024-02-14

    Amneal Phenoxybenzamine Hydrochloride Capsules 10mg Recalled Due to Unknown Impurity

    Amneal Pharmaceuticals is recalling Phenoxybenzamine Hydrochloride Capsules, 10mg, due to an unknown impurity. The recall affects 858 bottles distributed nationwide.

    Product
    Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1471-2022·2022-09-07

    Timolol Maleate eye drops recalled for unknown impurity in stability testing

    Akorn, Inc. is recalling Timolol Maleate Ophthalmic Solution due to identification of an unknown impurity during 12-month stability testing. No illnesses have been reported.

    Product
    Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1071-2020·2020-04-08

    Par Pharmaceutical Recalls Glycopyrrolate Tablets Due to Unknown Impurity

    Par Pharmaceutical is recalling 29,352 bottles of Glycopyrrolate Tablets, USP 1 mg, because an unknown impurity was detected.

    Product
    Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1848-2019·2019-09-18

    Mylan Recalls Gatifloxacin Ophthalmic Solution Due to Unknown Impurity

    Mylan Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to an out-of-specification result for an unknown impurity.

    Product
    Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1742-2019·2019-08-07

    Piramal Recalls Gablofen Baclofen Injection Due to Unknown Impurity

    Piramal Critical Care is recalling Gablofen (baclofen injection) due to the presence of an unknown impurity observed during shelf life.

    Product
    GABLOFEN — GABLOFEN (BACLOFEN INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1283-2015·2015-08-12

    Teva Recalls Amphetamine Tablets Due to Unknown Impurity

    Teva Pharmaceuticals is recalling specific lots of amphetamine tablets because they failed impurity specifications. The product contains an unknown impurity.

    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