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.

76–100 of 458

  • HighFDA (Drugs)·D-0283-2024·2024-02-07

    Antibiotic Rifampin Capsules Recalled for Subpotency and Quality Failures

    Lupin Pharmaceuticals recalled 15,576 bottles of Rifampin antibiotic capsules due to subpotency and failed quality specifications. The affected lots did not meet pharmaceutical standards for drug strength and purity.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0284-2024·2024-02-07

    Rifampin Antibiotic Capsules Recalled for Subpotency and Failed Specifications

    Lupin Pharmaceuticals recalls Rifampin 300mg capsules (lot A200817, exp 1/2024) due to subpotency and failed impurities/degradation specifications. Patients should consult their doctor before stopping medication.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0285-2024·2024-02-07

    Rifampin Capsules Recalled Due to Failed Impurity and Degradation Specification

    Amerisource Health Services is recalling Rifampin 150 mg capsules because they failed to meet impurity and degradation specifications. The recall affects 1,568 cartons distributed nationwide.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0213-2024·2024-01-10

    Prescription Oral Solution Eprontia Recalled for Out-of-Specification Impurity

    Azurity Pharmaceuticals recalls Eprontia (topiramate) oral solution nationwide because routine stability testing found an out-of-specification impurity. The chemical defect raised concerns about the drug's purity and patient safety.

    Product
    EPRONTIA — EPRONTIA (TOPIRAMATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0121-2024·2023-12-06

    Paroxetine Hydrochloride 30 mg Tablets Recalled for Impurity Specification Failure

    Apotex Corp. is recalling nationwide 25,776 units of Paroxetine Hydrochloride 30 mg tablets due to out-of-specification impurities. Affected lot numbers RV8686, RX0119, and RV2254 expire 08/2024.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0122-2024·2023-12-06

    Paroxetine Hydrochloride Tablets Recalled for Out-of-Specification Impurity

    Apotex Corp. is recalling Paroxetine Hydrochloride 40 mg tablets nationwide due to failed quality specifications. Testing found out-of-specification impurity levels in affected lot numbers.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0128-2024·2023-12-06

    Paroxetine Tablets Recalled Due to Out-of-Specification Impurity Levels

    Paroxetine tablets are being recalled for failing specification tests due to higher-than-acceptable levels of a degradation impurity. Approximately 1,941 bottles distributed nationwide are affected.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0130-2024·2023-12-06

    Paroxetine 40 mg tablets recalled for out-of-specification impurities

    Golden State Medical Supply Inc. is recalling Paroxetine 40 mg tablets due to failed impurity specifications. A total of 5,626 bottles were distributed nationwide.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0120-2024·2023-12-06

    Paroxetine Tablets Recalled Due to Manufacturing Specification Failure

    Apotex Corp. is recalling Paroxetine Hydrochloride 20 mg tablets nationwide due to out-of-specification impurity levels in affected lots. No illnesses have been reported.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0129-2024·2023-12-06

    Paroxetine 20 mg Tablets Recalled for Out-of-Specification Impurity

    Golden State Medical Supply is recalling certain lots of Paroxetine 20 mg tablets nationwide due to an out-of-specification chemical impurity in the product.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0089-2024·2023-11-15

    Hydrocortisone and Acetic Acid Otic Solution recalled for failed specifications

    Taro Pharmaceuticals recalls 11,196 bottles of Hydrocortisone and Acetic Acid Otic Solution nationwide due to failed quality specifications including out-of-spec impurities and lower-than-established assay levels discovered during stability testing.

    Product
    HYDROCORTISONE AND ACETIC ACID — HYDROCORTISONE AND ACETIC ACID (HYDROCORTISONE AND ACETIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0083-2024·2023-11-08

    Liothyronine Sodium Tablets Recalled for Failed Impurity and Degradation Specifications

    Sun Pharmaceutical is recalling 7,392 bottles of Liothyronine Sodium Tablets (Lot DND0058A) nationwide due to failed impurity and degradation specifications. Patients should contact their healthcare provider.

    Product
    LIOTHYRONINE SODIUM — LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0084-2024·2023-11-08

    Liothyronine Sodium Tablets Recalled for Failed Impurity Specifications

    Sun Pharmaceutical is recalling approximately 2,304 bottles of Liothyronine Sodium Tablets, USP, 25 mcg (lot DNC2204A) due to failed impurity and degradation specifications. The affected medication was distributed nationwide.

    Product
    LIOTHYRONINE SODIUM — LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0085-2024·2023-11-08

    Bisoprolol Fumarate and Hydrochlorothiazide Tablets Recalled for Failed Quality Specifications

    Glenmark Pharmaceuticals is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets due to failed impurities and degradation specifications. The recall affects 480 bottles distributed nationwide.

    Product
    BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0039-2024·2023-10-11

    HydrALAZINE Hydrochloride Tablets recalled due to impurity specifications failure

    Amerisource Health Services LLC is recalling HydrALAZINE Hydrochloride Tablets, 10 mg, nationwide due to impurities exceeding specifications in a repackaged product batch.

    Product
    HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0909-2023·2023-07-19

    Allergy Relief Fexofenadine Tablets Recalled for Failed Impurity Specifications

    L. Perrigo's Allergy Relief 180 mg tablets are being recalled due to failed impurity and degradation specifications. The recall affects 32,904 cartons distributed nationwide.

    Product
    ALLERGY RELIEF — ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0901-2023·2023-07-19

    Berkley Jensen Allergy Relief Recalled for Failed Quality Specifications

    L. Perrigo Company is recalling Berkley Jensen Allergy Relief tablets due to failed product quality specifications involving impurities and degradation. Consumers should verify their lot numbers and expiration dates.

    Product
    BERKLEY JENSEN ALLERGY RELIEF — BERKLEY JENSEN ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0902-2023·2023-07-19

    Careone Allergy Relief tablets recalled for failed impurity and degradation specifications

    Careone Allergy Relief fexofenadine hydrochloride 180mg tablets are recalled nationwide for failing impurity and degradation specifications. Lot 2JE2185 with expiration date 01/24 is affected.

    Product
    CAREONE ALLERGY RELIEF — CAREONE ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0914-2023·2023-07-19

    FDA Recalls Tiagabine Hydrochloride Tablets Due to Impurity Specification Failures

    Sun Pharmaceutical is recalling Tiagabine Hydrochloride Tablets (2 mg) due to out-of-specification impurities detected during testing. The recall affects lot HAC3339A distributed nationwide.

    Product
    TIAGABINE HYDROCHLORIDE — TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0912-2023·2023-07-19

    OTC Allergy Relief Tablets Recalled for Failed Manufacturing Specifications

    Topcare Allergy Relief 180 mg tablets recalled for failed impurity and degradation specifications. The recall affects 44,280 cartons distributed nationwide.

    Product
    TOPCARE ALLERGY RELIEF — TOPCARE ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0904-2023·2023-07-19

    OTC Antihistamine Tablets Recalled for Failed Quality Specifications

    L. Perrigo Company is recalling 1,920 cartons of Exchange Select Aller Ease (Fexofenadine Hydrochloride) 180 mg tablets nationwide due to failed impurity and degradation specifications.

    Product
    EXCHANGE SELECT ALLER EASE — EXCHANGE SELECT ALLER EASE (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0905-2023·2023-07-19

    Kirkland Signature Aller Fex Allergy Tablets Recalled for Failed Impurities Specifications

    L. Perrigo Company recalls Kirkland Signature Aller Fex allergy tablets nationwide due to certain lots failing impurities and degradation quality specifications. Consumers with affected lots should contact their healthcare provider.

    Product
    KIRKLAND SIGNATURE ALLER FEX — KIRKLAND SIGNATURE ALLER FEX (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0906-2023·2023-07-19

    OTC Allergy Relief Medication Recalled for Failed Quality Specifications

    L. Perrigo Company is recalling approximately 59,688 cartons of Fexofenadine Hydrochloride 180 mg allergy relief tablets nationwide because the product failed to meet FDA specifications for impurities and degradation.

    Product
    ALLERGY RELIEF — ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide