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.

176–200 of 297

  • LowFDA (Drugs)·D-1121-2019·2019-04-17

    Lupin Recalls Telmisartan and Amlodipine Tablets Due to Stability Failures

    Lupin Pharmaceuticals is recalling 12,504 bottles of Telmisartan and Amlodipine tablets because they failed impurity and degradation specifications in a long-term stability study.

    Product
    TELMISARTAN AND AMLODIPINE — TELMISARTAN AND AMLODIPINE (TELMISARTAN AND AMLODIPINE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1122-2019·2019-04-17

    AvKARE Recalls Telmisartan and Amlodipine Tablets Due to Impurities

    AvKARE Inc. is recalling Telmisartan and Amlodipine Tablets 80 mg/5 mg due to failed impurities and degradation specifications.

    Product
    Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1071-2019·2019-04-10

    Pfizer Recalls Clindamycin Injection Due to Impurity Specification Failures

    Pfizer is recalling specific lots of Clindamycin Injection because high out-of-specification impurities were found at the 24-month time point.

    Product
    Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1072-2019·2019-04-10

    Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures

    Pfizer is recalling specific lots of Clindamycin Injection due to high out-of-specification impurity results at the 24-month time point.

    Product
    Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1057-2019·2019-04-03

    Lupin Recalls Fayosim Tablets Due to Impurity Test Failures

    Lupin Pharmaceuticals is recalling specific lots of Fayosim tablets because they failed impurity specifications during stability testing.

    Product
    Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0993-2019·2019-03-20

    Akorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Impurities

    Akorn, Inc. is recalling Gentamicin Sulfate Ophthalmic Solution, 0.3%, due to high out-of-specification impurities found during stability testing.

    Product
    Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0512-2019·2019-02-27

    Perrigo Recalls Ciclopirox Shampoo Due to Stability Testing Failures

    Perrigo New York, Inc. is recalling specific lots of Ciclopirox shampoo 1% because stability testing revealed out-of-specification related substances.

    Product
    CICLOPIROX — CICLOPIROX (CICLOPIROX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0506-2019·2019-02-27

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 180mg because routine stability testing found high out-of-specification impurities.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0390-2019·2019-01-30

    Lupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurities

    Lupin Pharmaceuticals is recalling 24,180 bottles of Fluocinolone Acetonide Topical Solution due to elevated impurities.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1208-2019·2018-12-05

    Akorn Recalls Clindamycin Phosphate Topical Solution Due to Impurity Failures

    Akorn, Inc. is recalling 58,393 jars of Clindamycin Phosphate Topical Solution USP, 1% because the product failed impurity and degradation specifications.

    Product
    Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0244-2019·2018-11-21

    Teva Recalls Alprostadil Injection Due to Impurity Testing Failures

    Teva Pharmaceuticals is recalling Alprostadil Injection vials because routine stability testing revealed out-of-specification impurities.

    Product
    Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0281-2019·2018-10-31

    Upsher Smith Recalls Bumetanide Tablets for Unspecified Degradation Product

    Upsher Smith Laboratories is recalling 29,080 bottles of Bumetanide 2 mg tablets because the product failed impurity specifications for an unspecified degradation product.

    Product
    BUMETANIDE — BUMETANIDE (BUMETANIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1186-2018·2018-09-19

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing revealed out-of-specification results for related compounds.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1112-2018·2018-08-29

    Mylan Recalls Diltiazem HCl Extended-release Capsules Due to Impurities

    Mylan Institutional, Inc. is recalling 408 cartons of Diltiazem HCl Extended-release Capsules, 120 mg, due to out-of-specification impurities.

    Product
    Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1079-2018·2018-08-22

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

    Dr. Reddy's is recalling 40 mg Atorvastatin Calcium tablets because stability testing showed impurity levels exceeding specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1050-2018·2018-08-08

    Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Stability Test Failure

    Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because an out-of-specification result was found in a stability study. The product was distributed throughout the United States.

    Product
    MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0979-2018·2018-08-01

    Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities

    Major Pharmaceuticals is recalling specific lots of Enalapril Maleate Tablets, 2.5 mg, because the product failed impurity specifications for a degradation product.

    Product
    Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distribute
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0980-2018·2018-08-01

    Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities

    Major Pharmaceuticals is recalling 5,933 cartons of Enalapril Maleate Tablets, 5 mg, due to out-of-specification degradation products.

    Product
    Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0912-2018·2018-07-18

    Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures

    Wockhardt Limited is recalling specific batches of Enalapril Maleate Tablets USP because they failed impurity and degradation specifications.

    Product
    Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0913-2018·2018-07-18

    Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures

    Wockhardt Limited is recalling specific batches of Enalapril Maleate Tablets USP because they failed impurity and degradation specifications.

    Product
    Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0915-2018·2018-07-18

    American Health Packaging Recalls Enalapril Maleate Tablets Due to Impurities

    American Health Packaging is recalling specific lots of Enalapril Maleate Tablets USP, 5 mg, due to out-of-specification results for a degradation product.

    Product
    Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0886-2018·2018-06-27

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium tablets because they failed impurities and degradation specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide