The Recall Desk

Hazard

Foreign Substance recalls

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

What the numbers show

Total
212
Critical
0
Severe
42
Most recent
2026-08-19

Of the 212 foreign substance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 42 (20%) 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 foreign substance 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.

76–100 of 212

  • SevereFDA (Drugs)·D-0531-2020·2019-12-04

    Ibuprofen Oral Suspension Recalled for Inert Plastic Particles

    Preferred Pharmaceuticals is recalling specific lots of Ibuprofen Oral Suspension USP due to the presence of small particles of inert plastic material.

    Product
    Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0518-2020·2019-11-27

    Teva Recalls Valganciclovir Hydrochloride Oral Solution Due to Foreign Particles

    Teva Pharmaceuticals is recalling specific lots of Valganciclovir Hydrochloride for Oral Solution because brown or black particles were found during stability testing.

    Product
    VALGANCICLOVIR HYDROCHLORIDE FOR ORAL — VALGANCICLOVIR HYDROCHLORIDE FOR ORAL (VALGANCICLOVIR HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0532-2020·2019-11-20

    KVK-Tech Recalls Hydrocodone and Homatropine Oral Solution Due to Foreign Particles

    KVK-Tech is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution because black particles were found during inspection.

    Product
    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0186-2020·2019-11-13

    Mylan Recalls Alprazolam Tablets Due to Foreign Substance Presence

    Mylan Pharmaceuticals is recalling Alprazolam 0.5 mg tablets because they contain a foreign substance. Consumers should stop using the affected lot and contact their pharmacist.

    Product
    Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0304-2020·2019-11-13

    Lupin Recalls Cephalexin Oral Suspension Due to Foreign Substance

    Lupin Pharmaceuticals is recalling Cephalexin for Oral Suspension bottles because a dead ant was identified as a foreign substance.

    Product
    Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0298-2020·2019-11-06

    Taro Recalls Ibuprofen Oral Suspension Due to Foreign Plastic Particles

    Taro Pharmaceuticals is recalling specific lots of Ibuprofen Oral Suspension USP because they may contain small particles of inert plastic material introduced during manufacturing.

    Product
    IBUPROFEN — IBUPROFEN (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0301-2020·2019-11-06

    Taro Recalls Children's Ibuprofen Suspension Due to Plastic Particles

    Taro Pharmaceuticals is recalling 5,190 bottles of Children's Ibuprofen Oral Suspension because small particles of inert plastic may be present.

    Product
    IBUPROFEN — IBUPROFEN (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0299-2020·2019-11-06

    Taro Recalls Ibuprofen Oral Suspension Due to Foreign Plastic Particles

    Taro Pharmaceuticals is recalling 639,325 bottles of Ibuprofen Oral Suspension USP because they may contain small particles of inert plastic material introduced during manufacturing.

    Product
    IBUPROFEN — IBUPROFEN (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0302-2020·2019-11-06

    Taro Recalls Children's Ibuprofen Suspension Due to Plastic Particles

    Taro Pharmaceuticals is recalling 5,280 bottles of Children's Ibuprofen Oral Suspension due to the presence of small inert plastic particles.

    Product
    Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0142-2020·2019-10-23

    KVK-Tech Recalls Methylphenidate Hydrochloride Oral Solution Due to Foreign Particles

    KVK-Tech is recalling 384 bottles of Methylphenidate Hydrochloride Oral Solution because of the presence of fiber particles.

    Product
    Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1720-2019·2019-08-21

    Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Substance

    Lupin Pharmaceuticals is recalling specific bottles of Lisinopril and Hydrochlorothiazide tablets due to the presence of brownish or blackish stains and powder.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0389-2019·2019-01-30

    Dr. Reddy's Recalls Ezetimibe and Simvastatin Tablets Due to Foreign Substance

    Dr. Reddy's is recalling specific bottles of Ezetimibe and Simvastatin tablets because black speckles were observed on the tablets.

    Product
    Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0287-2019·2018-12-05

    Ascend Recalls Quetiapine Tablets Due to Metal Shard Contamination

    Ascend Laboratories is recalling Quetiapine 400 mg tablets because a metal shard was found in a tablet. Patients should stop using the affected lot and contact their healthcare provider.

    Product
    QUETIAPINE — QUETIAPINE (QUETIAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2019·2018-12-05

    Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance

    Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to confirmed foreign substance contamination.

    Product
    Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0517-2019·2018-12-05

    Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance

    Fresenius Medical Care is recalling specific lots of Granuflo Dry Acid Concentrate for hemodialysis due to the presence of a foreign substance.

    Product
    Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0516-2019·2018-12-05

    Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance

    Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to confirmed foreign substance contamination.

    Product
    Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0266-2019·2018-11-28

    L. Perrigo Recalls Calcium Carbonate Antacid Tablets Due to Metal Particles

    L. Perrigo is recalling specific lots of calcium carbonate antacid tablets because they were found to contain metal particles.

    Product
    Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-72, Distributed by DZA Brands, LLC, Salisbury, NC 28147, Scarborough, ME 04074], [HealthMart Pharmacy brand NDC: 62011-0295-1, Distributed by McKessen, One Post
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1077-2018·2018-08-22

    Lupin Recalls Lisinopril Tablets Due to Metal Contaminant

    Lupin Pharmaceuticals is recalling specific lots of Lisinopril tablets because a metal contaminant was found in one tablet.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0405-2018·2018-02-21

    Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination Risk

    Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab pack
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0408-2018·2018-02-21

    Sage Products Recalls Oral Care System Due to Cross Contamination

    Sage Products Inc. is recalling the Q Care Oral Cleansing & Suctioning System because it was manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.

    Product
    Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Ri
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0407-2018·2018-02-21

    Sage Products Recalls Q Care RX Oral System Due to Cross Contamination

    Sage Products is recalling 25 cases of Q Care RX Petite Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab package
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2018·2018-02-21

    Sage Products Recalls Oral Cleansing Systems Due to Cross-Contamination Risk

    Sage Products Inc. is recalling 2,199 cases of Oral Cleansing & Suctioning System q4 because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, 2 Untreated Suctino Toothbrush packages with Antiplaque solution, 4)Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Car
    Category
    Drug
    Distribution
    Distributed nationwide