The Recall Desk

Hazard

Degradation recalls

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

What the numbers show

Total
297
Critical
0
Severe
47
Most recent
2026-09-02

Of the 297 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 47 (16%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all 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.

251–275 of 297

  • ModerateFDA (Drugs)·D-0735-2016·2016-03-09

    Sun Pharma Recalls Alendronate Sodium Tablets Due to Impurity Levels

    Sun Pharma Global Fze is recalling specific lots of Alendronate Sodium Tablets 70 mg because unknown impurity levels exceeded specifications during stability testing.

    Product
    Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 416
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0725-2016·2016-03-02

    Zydus Recalls Risperidone Tablets Due to Impurity Failure

    Zydus Pharmaceuticals is recalling 9,504 bottles of 2 mg risperidone tablets because they failed impurity specifications. The affected lot is MP4967.

    Product
    risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0659-2016·2016-02-17

    Sandoz Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Sandoz Inc. is recalling Candesartan Cilexetil Tablets, 16 mg, because the product failed impurities and degradation specifications at a 9-month stability timepoint.

    Product
    Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0660-2016·2016-02-17

    Amerisource Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Amerisource Health Services is recalling 716 cartons of Candesartan Cilexetil Tablets, 16 mg, due to failed impurities and degradation specifications.

    Product
    Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0574-2016·2016-01-27

    PD-Rx Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    PD-Rx Pharmaceuticals is recalling 1,685 bottles of Phentermine Hydrochloride capsules because stability tests showed impurities exceeded specifications.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0054-2016·2015-10-28

    Hospira Recalls Amidate Etomidate Injection Due to Degradation Impurities

    Hospira Inc. is recalling 24,100 syringes of Amidate (Etomidate Injection) because stability testing confirmed out-of-specification degradation products.

    Product
    Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29
    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
  • SevereFDA (Drugs)·D-1236-2015·2015-07-22

    Kremers Urban Recalls Nitroglycerin Patches Due to Impurity Failure

    Kremers Urban Pharmaceuticals is recalling Nitroglycerin Transdermal Systems because they failed impurity specifications during stability testing.

    Product
    Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1139-2015·2015-06-24

    West-Ward Recalls Fentanyl Citrate Injection Due to Impurity Failures

    West-Ward Pharmaceutical Corp. is recalling Fentanyl Citrate Injection due to failed impurities and degradation specifications. The recall covers 14,649 cartons distributed nationwide.

    Product
    FENTANYL CITRATE — FENTANYL CITRATE (FENTANYL CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1130-2015·2015-06-17

    Akorn Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurities

    Akorn, Inc. is recalling Hydroxyzine Hydrochloride oral solution because it failed impurities and degradation specifications. The product was distributed nationwide, including Puerto Rico.

    Product
    Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1129-2015·2015-06-17

    Akorn Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurity Failures

    Akorn, Inc. is recalling 424,174 bottles of Hydroxyzine Hydrochloride oral solution because the product failed impurities and degradation specifications.

    Product
    Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0420-2015·2015-04-01

    West-Ward Recalls Fentanyl Citrate Injections Due to Impurity Failures

    West-Ward Pharmaceutical is recalling Fentanyl Citrate injections because the product failed impurity and degradation specifications and 12-month stability testing.

    Product
    FENTANYL CITRATE — FENTANYL CITRATE (FENTANYL CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0414-2015·2015-03-25

    Mutual Pharmaceutical Recalls Ergoloid Mesylates Tablets Due to Impurities

    Mutual Pharmaceutical is recalling Ergoloid Mesylates 1 mg tablets because they failed impurity and degradation specifications during stability testing.

    Product
    Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0404-2015·2015-03-11

    Pfizer Recalls Oxecta Tablets Due to Failed Impurity Specifications

    Pfizer is recalling 139 bottles of Oxecta (oxycodone HCl) 7.5 mg tablets because they failed impurity and degradation specifications.

    Product
    Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0403-2015·2015-03-11

    Pfizer Recalls Oxecta Tablets Due to Failed Impurity Specifications

    Pfizer is recalling 137 bottles of Oxecta (oxycodone HCl) 5 mg tablets because they failed impurity and degradation specifications.

    Product
    Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0288-2015·2014-12-10

    Sandoz Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Sandoz, Inc. is recalling 6,336 bottles of 16 mg candesartan cilexetil tablets because stability testing showed impurity levels exceeded specifications.

    Product
    candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0247-2015·2014-11-19

    Fresenius Kabi Recalls Haloperidol Decanoate Injection Due to Impurity Failure

    Fresenius Kabi is recalling Haloperidol Decanoate Injection vials due to an out-of-specification impurity result. The recall covers 216,517 vials distributed nationwide and in Puerto Rico.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0241-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 4 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0242-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling specific lots of Candesartan Cilexetil Tablets because they failed impurity and degradation specifications.

    Product
    Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0048-2015·2014-11-05

    Hi-Tech Pharmacal Recalls HydrOXYzine Hydrochloride Oral Solution Due to Impurity

    Hi-Tech Pharmacal Co., Inc. is recalling 451,916 bottles of HydrOXYzine Hydrochloride Oral Solution because an unknown impurity exceeded specifications during stability testing.

    Product
    HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0050-2015·2014-11-05

    Teva Recalls Dextroamphetamine Tablets Due to Unknown Impurities

    Teva Pharmaceuticals is recalling specific lots of dextroamphetamine tablets because they failed impurity specifications. The recall covers 19,545 bottles distributed nationwide.

    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
  • LowFDA (Drugs)·D-1484-2014·2014-09-03

    Novel Laboratories Recalls Famotidine Oral Suspension Due to Impurity Failure

    Novel Laboratories is recalling 25,776 containers of Famotidine Oral Suspension because the product failed an impurity specification. The recall is classified as FDA Class III.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1499-2014·2014-08-06

    Teva Recalls Lansoprazole Triple Therapy Blister Packs Due to Impurities

    Teva Pharmaceuticals is recalling 89,215 blister packs of triple therapy containing lansoprazole, clarithromycin, and amoxicillin due to failed impurity specifications.

    Product
    triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxici
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1435-2014·2014-07-23

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Institutional, Inc. is recalling Diltiazem HCl Extended-Release Capsules, 120 mg, due to high out-of-specification results for a related compound found during routine stability testing.

    Product
    Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
    Category
    Drug
    Distribution
    Distributed nationwide