The Recall Desk

Hazard

Impurity Degradation recalls

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

What the numbers show

Total
24
Critical
0
Severe
0
Most recent
2025-10-01

Of the 24 impurity degradation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 degradation 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.

1–24 of 24

  • LowFDA (Drugs)·D-0669-2025·2025-10-01

    Dextroamphetamine Saccharate and Amphetamine Capsules Recalled for Failed Impurities Specifications

    Granules Pharmaceuticals Inc. is recalling 3,384 bottles of mixed-salt amphetamine extended-release capsules (5 mg) distributed nationwide due to failed impurities and degradation specifications.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0443-2025·2025-05-28

    Esomeprazole Magnesium oral suspension recalled for failed impurity specifications

    Zydus Pharmaceuticals is recalling Esomeprazole Magnesium delayed-release oral suspension, 20 mg, due to out-of-specification test results for unknown degradation products detected during long-term stability testing.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0262-2023·2023-02-08

    Diltiazem Hydrochloride extended-release capsules recalled due to failed quality specifications

    Sun Pharmaceutical is recalling Diltiazem Hydrochloride Extended-Release Capsules (360 mg) due to failed impurity specifications and dissolution testing found during FDA laboratory evaluation. The recall affects five lot numbers distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0985-2022·2022-06-15

    Xiidra Ophthalmic Solution Recalled for Failed Impurity and Degradation Specifications

    Novartis is recalling Xiidra (lifitegrast ophthalmic solution) 5% professional samples nationwide due to failed impurities and degradation quality specifications. The recall affects 279,179 vials across three lot numbers.

    Product
    Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 0242
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0983-2022·2022-06-15

    Xiidra ophthalmic solution recalled for failed impurity and degradation specifications

    Novartis recalls approximately 1.25 million vials of Xiidra ophthalmic solution nationwide due to failed impurity and degradation specifications. Patients using this product should contact their healthcare provider.

    Product
    Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0653-2022·2022-03-23

    hydrALAZINE HCl Tablets 10 mg Recalled for Failed Impurity Specifications

    The Harvard Drug Group is recalling hydrALAZINE HCl Tablets, USP, 10 mg due to failed impurity and degradation specifications detected during routine stability testing. The recall affects 5,953 cartons distributed nationwide.

    Product
    hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0560-2022·2022-02-23

    Moxifloxacin Ophthalmic Solution Recall for Failed Impurities Specifications

    Aurobindo Pharma USA Inc. is recalling Moxifloxacin Ophthalmic Solution 0.5% due to failed impurities and degradation specifications. The recall affects 115,776 bottles distributed nationwide.

    Product
    MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0558-2022·2022-02-23

    Diazepam Oral Solution Recalled for Failed Impurity Specifications

    Lannett Company is recalling Diazepam Oral Solution (Concentrate) 5 mg/mL due to out-of-specification results for related substances, indicating failed impurities and degradation testing.

    Product
    Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0336-2022·2022-01-12

    DG/health Aller.Ease Fexofenadine Tablets Recalled for Impurity

    Perrigo Company PLC is recalling DG/health Aller.Ease Fexofenadine Hydrochloride 180 mg tablets nationwide because they failed impurity specifications during stability testing.

    Product
    DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle, Distributed by: Made in Czech Republic. Distributed by Dolgencorp, LLC, 100 Mission Ridge Goodlettsville, TN 37072. UPC 3 70030 65779 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0330-2022·2022-01-12

    Amazon Allergy Fexofenadine Hydrochloride Tablets Recalled for Failed Impurity Specifications

    Amazon-branded Allergy Fexofenadine Hydrochloride Tablets 180 mg are being recalled because testing found an out-of-specification impurity during stability testing.

    Product
    amazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count bottle, Made in the Czech Republic, Distributed by: Amazon.com Services LLC 410 Terry Avenue N. Seattle, WA 98109 UPC 3 70030 11466 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0345-2022·2022-01-12

    Perrigo Fexofenadine Hydrochloride 180mg tablets recalled for impurity

    Perrigo Company PLC is recalling Fexofenadine Hydrochloride 180mg antihistamine tablets due to an out-of-specification impurity result detected during stability testing. The recall affects approximately 89,664 containers distributed nationwide.

    Product
    Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0329-2022·2022-01-12

    GoodSense Aller.Ease fexofenadine tablets recalled for impurity specification failure

    Perrigo Company PLC is recalling GoodSense Aller.Ease fexofenadine hydrochloride 60 mg tablets nationwide due to failed impurity and degradation specifications identified during stability testing.

    Product
    GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic, Distributed by: Perrigo Allergan MI 49010.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0335-2022·2022-01-12

    CVS Allergy Relief Fexofenadine Tablets Recalled for Impurity

    CVS Allergy Relief Fexofenadine Hydrochloride Tablets 60 mg are being recalled because stability testing found an out-of-specification result for impurity A. The recall affects approximately 138,144 containers distributed nationwide.

    Product
    CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC 59779-425-53, UPC 0 50428 25414 1; b)24 count bottle, NDC 59779-425-62, UPC 0 50428 53435 9; Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0341-2022·2022-01-12

    Kroger Allergy Relief Fexofenadine Tablets Recalled for Impurity

    Perrigo Company is recalling Kroger Allergy Relief Fexofenadine Hydrochloride 60mg tablets due to an out-of-specification impurity detected during stability testing.

    Product
    Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0338-2022·2022-01-12

    Health Mart Fexofenadine Hydrochloride 180mg Tablets Recall

    Perrigo Company is recalling Health Mart Fexofenadine Hydrochloride 180mg antihistamine tablets due to failed impurity specifications detected during stability testing. The recall affects approximately 6,960 containers distributed nationwide.

    Product
    Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0233-1, UPC 0 52569 13787 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0351-2022·2022-01-12

    Up&Up Allergy Relief 180mg Tablets Recalled for Failed Impurity Specification

    Perrigo Company PLC is recalling up&up allergy relief fexofenadine hydrochloride 180mg tablets distributed nationwide because stability testing found impurity A exceeded specifications. The affected products are 15-count and 30-count bottles with specific lot numbers and expiration dates.

    Product
    up&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihistamine, packaged as a) 15 count bottle, NDC 11673-571-22 UPC 3 70030 62303 7; b) 30 count bottle, NDC 11673-571-39 UPC 3 70030 62301 3; Distributed by Target Corp., Mpls., MN 55403, Made in the Czech Re
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0339-2022·2022-01-12

    H.E.B Allergy Relief Fexofenadine tablets recalled for impurity specification failure

    Perrigo Company is recalling H.E.B Allergy Relief fexofenadine hydrochloride 60mg tablets nationwide due to failure of impurity specifications during stability testing.

    Product
    H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0332-2022·2022-01-12

    Fexofenadine Hydrochloride Tablets Recall for Failed Impurity Specifications

    Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets, 60 mg, 100-count bottles, due to out-of-specification impurity levels detected during stability testing.

    Product
    basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7425-78 UPC 3 70030 14536 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0328-2022·2022-01-12

    EQUALINE Fexofenadine Hydrochloride Tablets Recalled for Failed Impurity Testing

    Perrigo Company is recalling EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, due to impurity A exceeding specification limits during stability testing. The recalled products were distributed nationwide.

    Product
    EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0352-2022·2022-01-12

    Wal-Fex Fexofenadine Hydrochloride Tablets Recalled for Impurity Specification Failure

    Perrigo Company PLC is recalling Wal-Fex Fexofenadine Hydrochloride 180mg tablets distributed nationwide because impurity A levels exceeded specifications during stability testing.

    Product
    Wal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, packaged as a) 5 count bottle, NDC 0363-0600-13,UPC 3 11917 12267 0, b)30 count bottle, NDC 0363-0600-39 UPC 3 11917 16172 3 c) 90 count bottle, NDC 0363-0600-75 UPC 3 11917 12271 7 ; Distributed by Walgree
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0343-2022·2022-01-12

    Meijer Fexofenadine Hydrochloride Allergy Relief Tablets Recalled

    Meijer allergy relief tablets containing fexofenadine hydrochloride are being recalled nationwide due to out-of-specification impurity results found during stability testing.

    Product
    Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 41250-060-22 UPC 7 60236 18716 5; b) 30 count bottle, NDC 41250-060-39, UPC 7 60236 18717 2; c) 45 count bottle, NDC 41250-060-95, UPC 7 60236 18732 5; Made
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0802-2021·2021-09-22

    Betamethasone Dipropionate Lotion recalled for unknown impurity

    Akorn, Inc. is recalling Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, due to an unknown impurity found in the product that exceeds specification limits. The affected lots were distributed nationwide.

    Product
    Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0244-2021·2021-02-03

    Bausch Health Recalls Phytonadione Tablets Due to Impurity D

    Bausch Health is recalling Phytonadione Tablets 5mg because Impurity D exceeded specifications during stability testing. The recall covers 14,089 bottles distributed nationwide.

    Product
    Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0333-2015·2015-01-14

    Akorn Recalls Triamcinolone Acetonide Lotion Due to Impurity Specification Failure

    Akorn, Inc. is recalling 3,937 bottles of Triamcinolone Acetonide Lotion USP, 0.025% because a known impurity exceeded specifications at the 12-month stability point.

    Product
    Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
    Category
    Drug
    Distribution
    Distributed nationwide