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.

126–150 of 458

  • ModerateFDA (Drugs)·D-0347-2022·2022-01-12

    Rite Aid Allergy Relief Fexofenadine Tablets Recalled for Impurity

    Rite Aid Allergy Relief Fexofenadine Hydrochloride 60mg tablets are being recalled due to failed impurity specifications detected during stability testing. The affected product was distributed nationwide.

    Product
    Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0349-2022·2022-01-12

    TopCare Allergy Relief Fexofenadine tablets recalled for impurity specification failure

    Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 60mg tablets (12-count bottles, Lot #0LE2178) distributed nationwide due to an out-of-specification impurity result found during stability testing.

    Product
    TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0355-2022·2022-01-12

    Kirkland Aller-Fex tablets recalled for impurity specification failure

    Perrigo Company is recalling Kirkland Aller-Fex fexofenadine hydrochloride 180 mg tablets nationwide because stability testing found out-of-specification impurity levels in affected lots.

    Product
    KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech Republic, Packaged by Perrigo 515 Eastern Ave., Allegan, MI 49010, For Costco Wholesale Corporation. P.O. Box 34535 Seattle, WA 98124-1535, NDC 63981-571-48, U
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0353-2022·2022-01-12

    Wal-Fex Fexofenadine Tablets Recalled for Impurity Specifications

    Perrigo Company is recalling Wal-Fex Fexofenadine Hydrochloride 60mg tablets due to out-of-specification impurity levels detected during stability testing. The recall affects 4,536 containers distributed nationwide.

    Product
    Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0088-2022·2021-11-10

    Irbesartan 300 mg tablets recalled for impurity in active ingredient

    Lupin Pharmaceuticals is recalling Irbesartan 300 mg tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects approximately 119,544 bottles distributed nationally.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0898-2021·2021-10-06

    Sodium Phenylbutyrate Powder Recalled for Impurity Specification Failures

    SigmaPharm Laboratories is recalling Sodium Phenylbutyrate Powder due to failed impurity and degradation specifications detected during routine testing. The affected lots are distributed nationwide.

    Product
    Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0640-2021·2021-06-30

    Metformin Hydrochloride Tablets Recalled for NDMA Contamination

    Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg due to detection of N-Nitrosodimethylamine (NDMA) levels exceeding acceptable daily intake limits.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0339-2021·2021-05-05

    Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity Failures

    Teligent Pharma is recalling 79,416 tubes of Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) because the product failed impurity specifications.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0338-2021·2021-05-05

    Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity Failure

    Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% because it failed impurity specifications for a known degradation product.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0340-2021·2021-05-05

    Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity

    Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% due to failed impurity specifications. The product is distributed nationwide in 15-gram tubes.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2021·2021-04-28

    Teligent Pharma Recalls Flurandrenolide Ointment Due to Impurity Failures

    Teligent Pharma is recalling 3,432 tubes of Flurandrenolide Ointment 0.05% because the product failed impurity and degradation specifications.

    Product
    Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0301-2021·2021-03-24

    Akorn Recalls Gabapentin Oral Solution Due to Impurity Specifications

    Akorn, Inc. is recalling Gabapentin Oral Solution because it failed impurity specifications during stability testing. The product was distributed nationwide.

    Product
    Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0309-2021·2021-03-24

    Teva Recalls Romidepsin Injection Vials Due to Impurity Failures

    Teva Pharmaceuticals is recalling 1,416 vials of Romidepsin Injection because stability testing revealed out-of-specification impurities.

    Product
    Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0264-2021·2021-02-24

    Ascend Recalls Cephalexin Oral Suspension Due to CGMP Deviations

    Ascend Laboratories LLC is recalling Cephalexin for Oral Suspension due to CGMP deviations involving unidentified impurities.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0263-2021·2021-02-24

    Ascend Recalls Cephalexin Oral Suspension Due to Impurity Levels

    Ascend Laboratories is recalling Cephalexin for Oral Suspension because unidentified impurities were found at higher levels than allowed.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0247-2021·2021-02-10

    Lupin Recalls Oseltamivir Phosphate Oral Suspension Due to Impurity Issues

    Lupin Pharmaceuticals is recalling 46,479 bottles of Oseltamivir Phosphate oral suspension because out-of-specification test results were found for Impurity C during stability testing.

    Product
    OSELTAMIVIR PHOSPHATE — OSELTAMIVIR PHOSPHATE (OSELTAMIVIR PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0224-2021·2021-01-20

    KVK-Tech Recalls Benzhydrocodone and Acetaminophen Tablets Due to Impurity

    KVK-Tech, Inc. is recalling 528 bottles of Benzhydrocodone and Acetaminophen Tablets because the N-Oxide impurity exceeded specifications during stability testing.

    Product
    Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0179-2021·2021-01-06

    Ascend Cephalexin Oral Suspension Recalled for Impurity Specification Failures

    Ascend Laboratories is recalling Cephalexin for Oral Suspension because it failed impurity and degradation specifications. The recall covers 9,524 bottles distributed nationwide.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0174-2021·2020-12-30

    Morton Grove Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurities

    Morton Grove Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution because it failed impurity specifications, including an unknown degradant.

    Product
    Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0150-2021·2020-12-23

    Taro Recalls Clotrimazole Cream Due to Unknown Degradation Impurity

    Taro Pharmaceuticals is recalling CVS Health Athlete's Foot Cream because an unknown degradation impurity was detected slightly above the specification limit.

    Product
    CLOTRIMAZOLE 1% — CLOTRIMAZOLE 1% (CLOTRIMAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide