The Recall Desk

Hazard

Impurities recalls

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

What the numbers show

Total
191
Critical
4
Severe
23
Most recent
2026-08-05

Of the 191 impurities recalls we have scored against our rubric, 4 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 23 (12%) 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 impurities 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.

101–125 of 191

  • 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
  • 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
  • ModerateFDA (Drugs)·D-0888-2018·2018-06-27

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

    Dr. Reddy's Laboratories is recalling 130,081 bottles of Atorvastatin Calcium 40 mg tablets nationwide due to failed impurity and degradation specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0839-2018·2018-05-23

    Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials

    Apotex Inc. is recalling 121,693 vials of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.

    Product
    Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0840-2018·2018-05-23

    Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials

    Apotex Inc. is recalling specific lots of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.

    Product
    Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0599-2018·2018-03-21

    Novel Laboratories Recalls Hydrocodone Bitartrate and Homatropine Methylbromide Tablets

    Novel Laboratories is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide tablets due to failed impurities and degradation specifications.

    Product
    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0418-2018·2018-02-07

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

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium 10 mg tablets because stability testing showed out-of-specification results for total degradation impurities.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0230-2018·2018-01-31

    Mylan Recalls Bupropion HCL Extended-Release Tablets Due to Impurities

    Mylan Pharmaceuticals is voluntarily recalling specific bottles of bupropion HCL extended-release tablets due to out-of-specification impurities found during routine stability testing.

    Product
    bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0107-2018·2017-12-13

    Elite Laboratories Recalls Isradapine Capsules Due to Impurity Failures

    Elite Laboratories Inc. is recalling 1,264 bottles of Isradapine Capsules USP 2.5 mg in New York due to failed impurities and degradation specifications.

    Product
    Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0093-2018·2017-11-29

    West-Ward Recalls Dexamethasone Sodium Phosphate Injection Due to Impurities

    West-Ward Pharmaceuticals is recalling specific lots of Dexamethasone Sodium Phosphate Injection because of high out-of-specification results for a related compound.

    Product
    DEXAMETHASONE SODIUM PHOSPHATE — DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0077-2018·2017-11-22

    Allergan Recalls Combigan Eye Drops Due to Failed Impurity Specifications

    Allergan is recalling 715,041 bottles of Combigan ophthalmic solution because the product failed impurities and degradation specifications.

    Product
    COMBIGAN — COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0005-2018·2017-10-11

    Vi-Jon Recalls Magnesium Citrate Oral Solution for Impurity Failures

    Vi-Jon, Inc. is recalling 348,384 bottles of Magnesium Citrate Oral Solution because the product failed impurities and degradation specifications.

    Product
    Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 59779-667-38, UPC 05042842790; b) Swan Citroma, Distributed by: Vi-Jon O
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0006-2018·2017-10-11

    Vi-Jon Recalls Magnesium Citrate Oral Solution for Impurity Failures

    Vi-Jon, Inc. is recalling 87,972 bottles of Magnesium Citrate Oral Solution because the product failed impurities and degradation specifications.

    Product
    Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in 10 fl. oz ( 296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 6984238038, UPC 050428418321, b) Meijer, Dist. By Meijer Distribution,
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1118-2017·2017-08-30

    PD-Rx Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    PD-Rx Pharmaceuticals is recalling 3,440 bottles of Phentermine Hydrochloride capsules because stability tests showed out-of-specification unknown impurities.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1039-2017·2017-08-09

    Teva Recalls Albuterol Sulfate Inhalation Solution Due to Impurities

    Teva Pharmaceuticals USA is recalling Albuterol Sulfate Inhalation Solution because high levels of a related compound were detected.

    Product
    Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0984-2017·2017-07-26

    Teva Recalls Buprenorphine and Naloxone Tablets Due to Impurities

    Teva Pharmaceuticals is recalling Buprenorphine and Naloxone Sublingual Tablets because test results showed out-of-specification impurities.

    Product
    Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0983-2017·2017-07-26

    Teva Recalls Buprenorphine and Naloxone Tablets Due to Impurities

    Teva Pharmaceuticals is recalling specific lots of Buprenorphine and Naloxone Sublingual Tablets because they failed impurity specifications.

    Product
    Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0929-2017·2017-07-05

    Allergan Recalls Blephamide Ophthalmic Ointment Due to Impurity Failures

    Allergan is recalling 648 units of Blephamide ophthalmic ointment because stability testing showed impurities exceeding specifications.

    Product
    Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0700-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 7.5 mg, because they failed impurity specifications. The recall covers 6,138 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceut
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0702-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 20 mg, because they failed impurity specifications. The recall covers 14,784 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuti
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0699-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling specific lots of Olanzapine Tablets, 2.5 mg, because they failed impurity specifications.

    Product
    Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0701-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 10 mg, because they failed impurity specifications. The recall covers 38,316 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuti
    Category
    Drug
    Distribution
    Distributed nationwide