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.

301–325 of 458

  • SevereFDA (Drugs)·D-1146-2018·2018-09-05

    RemedyRepack Recalls Amlodipine/Valsartan/HCTZ Tablets Due to NDMA Contamination

    RemedyRepack Inc. is recalling Amlodipine/Valsartan/HCTZ tablets in South Carolina due to trace amounts of NDMA, a possible impurity.

    Product
    Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1168-2018·2018-09-05

    Akorn Recalls Azelastine HCl Ophthalmic Solution Due to Impurities

    Akorn, Inc. is recalling specific lots of Azelastine HCl Ophthalmic Solution 0.05% because of out-of-specification results for Azelastine N-oxide.

    Product
    Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
    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
  • SevereFDA (Drugs)·D-1046-2018·2018-08-15

    Akorn Recalls Lidocaine and Prilocaine Cream Due to Impurity

    Akorn, Inc. is recalling Lidocaine 2.5% and Prilocaine Cream because routine stability testing found an unknown impurity.

    Product
    Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30
    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-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-0887-2018·2018-06-27

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

    Dr. Reddy's Laboratories is recalling specific lots of Atorvastatin Calcium tablets because they failed impurity and degradation specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0828-2018·2018-05-16

    Septodont Recalls OraVerse Injection Due to Impurity Test Failure

    Septodont Inc. is recalling OraVerse (Phentolamine Mesylate) Injection due to an out-of-specification result for a degradation product impurity.

    Product
    ORAVERSE — ORAVERSE (PHENTOLAMINE MESYLATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0698-2018·2018-04-18

    InvaGen Recalls Decitabine for Injection Due to Impurity Failures

    InvaGen Pharmaceuticals is recalling Decitabine for Injection because the product failed water content and impurity specifications.

    Product
    Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0617-2018·2018-03-28

    Akorn Recalls Triamcinolone Acetonide Lotion Due to Impurity Levels

    Akorn, Inc. is recalling 4,128 bottles of Triamcinolone Acetonide Lotion, USP 0.1% due to high impurity levels. The product was distributed nationwide and in Puerto Rico.

    Product
    Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0588-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling methylprednisolone sodium succinate for injection vials due to high impurity levels. The affected lots were distributed nationwide.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0586-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling 205,370 vials of methylprednisolone sodium succinate for injection due to high impurity levels.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0587-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling 176,410 vials of methylprednisolone sodium succinate injection due to high impurity levels.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0578-2018·2018-02-21

    Teva Recalls Fluoxetine Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals USA is voluntarily recalling Fluoxetine Tablets USP, 10 mg, because routine stability testing revealed an out-of-specification lactoside impurity.

    Product
    Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0542-2018·2018-02-14

    Teva Recalls Fentanyl Transdermal Systems Due to Impurity Levels

    Teva Pharmaceuticals is recalling specific lots of Fentanyl Transdermal Systems because they contain a degradant called Fentanyl-n-Oxide that exceeds safety limits.

    Product
    Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0543-2018·2018-02-14

    Teva Recalls Fentanyl Transdermal Systems Due to Impurity Exceeding Limits

    Teva Pharmaceuticals is recalling specific lots of Fentanyl Transdermal Systems because a degradation product exceeded safety limits.

    Product
    Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0541-2018·2018-02-14

    Teva Recalls Fentanyl Patches Due to Impurity Exceeding Limits

    Teva Pharmaceuticals is recalling Fentanyl Transdermal Systems because a degradation product exceeded safety limits.

    Product
    Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0426-2018·2018-02-07

    Fresenius Kabi Recalls Vecuronium Bromide Vials Due to Impurity Failure

    Fresenius Kabi USA is recalling 35,620 vials of Vecuronium bromide for Injection due to an out-of-specification result for a related compound.

    Product
    Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0419-2018·2018-02-07

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

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium 20 mg tablets because stability testing revealed out-of-specification total degradation impurities.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0208-2018·2018-01-17

    Teva Recalls Moexipril Hydrochloride Tablets Due to Impurity Test Failure

    Teva Pharmaceuticals is recalling specific bottles of Moexipril Hydrochloride and Hydrochlorothiazide tablets because routine stability testing found high levels of a degradation impurity.

    Product
    Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0108-2018·2017-12-20

    Teva Recalls Penicillin V Potassium Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling specific bottles of Penicillin V Potassium oral solution because they failed impurity and degradation specifications.

    Product
    PENICILLIN V POTASSIUM — PENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0094-2018·2017-11-29

    West-Ward Recalls Dexamethasone Sodium Phosphate Injection Due to Impurity

    West-Ward Pharmaceuticals is recalling Dexamethasone Sodium Phosphate Injection due to high levels of a related compound impurity.

    Product
    DEXAMETHASONE SODIUM PHOSPHATE — DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0055-2018·2017-11-08

    AvKARE Recalls Duloxetine Capsules Due to Slightly Elevated Phthalic Acid

    AvKARE is recalling 274 cartons of Duloxetine Delayed-release Capsules 20 mg due to slightly elevated levels of phthalic acid.

    Product
    Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0053-2018·2017-11-01

    Aidarex Recalls Enalapril Maleate Tablets Due to Impurity Failures

    Aidarex Pharmaceuticals is recalling specific lots of Enalapril Maleate 5mg tablets distributed in Florida due to out-of-specification impurities.

    Product
    ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
    Category
    Drug
    Distribution
    1 state