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.

51–75 of 212

  • HighFDA (Devices)·Z-2425-2025·2025-09-03

    Limb salvage stem extensions recalled after unidentified substance found on devices

    ELEOS Segmental Limb Salvage System straight splined slotted stem extensions are recalled because an unidentified substance of unknown impact was found on devices during a retrospective evaluation. 554 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0574-2025·2025-08-13

    Spironolactone 25 mg tablets recalled after aluminum was found in product

    Spironolactone Tablets USP 25 mg are being recalled because of the presence of a foreign substance identified as aluminum. 11,328 bottles are affected.

    Product
    SPIRONOLACTONE — SPIRONOLACTONE (SPIRONOLACTONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0509-2025·2025-07-16

    Famciclovir tablets recalled after a hair was found on a tablet

    Famciclovir Tablets USP 500 mg from Macleods Pharma are being recalled because a black hair strand was found attached to a tablet in a sealed bottle. 9,888 bottles are affected.

    Product
    FAMCICLOVIR — FAMCICLOVIR (FAMCICLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0563-2024·2024-07-03

    Progesterone 200 mg compounded tablets recalled for embedded metal fragments

    Coast Quality Pharmacy is recalling Progesterone 200 mg compounded sublingual tablets nationwide due to discovery of broken metal pieces embedded in tablets. Patients should contact their healthcare provider.

    Product
    Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0078-2024·2023-11-08

    TUMS Antacid Tablets Recalled for Glass Mineral Wool Contamination

    GlaxoSmithKline is recalling TUMS Antacid 1000 mg chewable tablets in Assorted Berries flavor due to glass mineral wool contamination found in some bottles. Product was distributed nationwide.

    Product
    TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0074-2024·2023-11-08

    FDA Recalls TUMS Antacid Tablets for Glass Mineral Wool Contamination

    GlaxoSmithKline is recalling TUMS Antacid tablets (Lot HA7G, expiration 8/31/2027) due to contamination with glass mineral wool. The product was distributed nationwide.

    Product
    TUMS — TUMS (CALCIUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0943-2023·2023-08-02

    Safe Tussin PM Night Time Cough Relief Recalled for Manufacturing Deviation

    Kramer Laboratories is recalling Safe Tussin PM Night Time Cough Relief due to use of non-food-grade lubricant in the mixing vessel during manufacturing. Affected product: lot 8639, expiration 8/2023, distributed nationwide.

    Product
    Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0895-2023·2023-07-12

    Losartan Potassium Tablets Recalled for Blue Plastic Contamination

    Strides Pharma Inc. is recalling Losartan Potassium Tablets, 25 mg, due to the presence of blue plastic pieces embedded in tablets from lot 7901903A. No illnesses or injuries have been reported.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0085-2023·2022-12-28

    Oxcarbazepine 600mg tablets recalled for foreign substance contamination

    Sun Pharmaceutical is recalling three lots of Oxcarbazepine 600mg tablets due to the presence of foreign substances. The affected medication was distributed nationwide.

    Product
    OXCARBAZEPINE — OXCARBAZEPINE (OXCARBAZEPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0024-2023·2022-11-09

    Buprenorphine and Naloxone Sublingual Tablets Recalled for Foreign Substance

    Sun Pharmaceutical is recalling buprenorphine and naloxone sublingual tablets (8 mg/2 mg) due to a foreign substance. Affected lots DNC1129A and DNC1740A were distributed nationwide.

    Product
    BUPRENORPHINE AND NALOXONE — BUPRENORPHINE AND NALOXONE (BUPRENORPHINE AND NALOXONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0857-2022·2022-05-18

    Bupropion Hydrochloride 150 mg Extended-Release Tablets Recalled for Activated Carbon Contamination

    Sun Pharmaceutical is recalling Bupropion Hydrochloride 150 mg extended-release tablets distributed nationwide due to activated carbon particles from desiccant canisters found in bottles. No illnesses have been reported.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0746-2022·2022-04-13

    Diabetes Drug Janumet Recalled Due to Stainless Steel Contamination

    Merck is recalling 3,600 cartons of Janumet (sitagliptin/metformin HCl) tablets nationwide due to the presence of stainless steel particulates in the tablets.

    Product
    JANUMET — JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0719-2021·2021-08-18

    Sulfamethoxazole and Trimethoprim Tablets Recalled for Metal Contamination

    Aurobindo Pharma USA Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) due to potential metal contamination in the product. The recall affects approximately 3,800 bottles distributed nationwide.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0637-2021·2021-06-30

    DermOtic fluocinolone acetonide ear drops recalled for broken glass risk

    Hill Dermaceuticals is recalling DermOtic (fluocinolone acetonide) ear drops due to the potential for broken glass in the glass pipette dropper. The affected product was distributed nationwide.

    Product
    DERMOTIC — DERMOTIC (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0372-2021·2021-05-19

    Sun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Substance

    Sun Pharmaceutical Industries is recalling 50,868 bottles of Metformin Hydrochloride Extended-Release Tablets because activated carbon was found in the product.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1537-2020·2020-09-02

    Fresenius Kabi Recalls Dexmedetomidine Injection Due to Lidocaine Contamination

    Fresenius Kabi is recalling specific lots of Dexmedetomidine HCl Injection due to trace amounts of lidocaine contamination.

    Product
    Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1539-2020·2020-09-02

    Ecolab Recalls Hand Sanitizer Due to Discoloration and Foreign Substance

    Ecolab Inc is recalling 305 drums of 55-gallon hand sanitizer nationwide due to discoloration and the presence of a foreign substance.

    Product
    Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1289-2020·2020-06-10

    AvKARE Recalls Lamotrigine Tablets Due to Foreign Substance Presence

    AvKARE Inc. is recalling 4,124 bottles of Lamotrigine 150 mg tablets because they contain foreign substance consistent with desiccant pack granules.

    Product
    LAMOTRIGINE — LAMOTRIGINE (LAMOTRIGINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1281-2020·2020-06-03

    Lamotrigine Tablets Recalled for Presence of Foreign Silica Granules

    Jubilant Cadista Pharmaceuticals is recalling Lamotrigine Tablets, 150 mg, due to the presence of foreign silica granules consistent with desiccant pack material.

    Product
    Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0833-2020·2020-02-19

    Taro Recalls Lamotrigine Tablets Due to Enalapril Maleate Contamination

    Taro Pharmaceuticals is recalling Lamotrigine Tablets 100 mg because they were cross-contaminated with enalapril maleate. The affected lot was distributed nationwide in the U.S. and Puerto Rico.

    Product
    LAMOTRIGINE — LAMOTRIGINE (LAMOTRIGINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0852-2020·2020-02-19

    AuroMedics Recalls Amoxicillin and Clavulanate Potassium Tablets Due to Foreign Substance

    AuroMedics Pharma LLC is recalling 30,432 bottles of Amoxicillin and Clavulanate Potassium tablets because a customer complaint identified a nylon cable tie as a foreign substance.

    Product
    AMOXICILLIN AND CLAVULANATE POTASSIUM — AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide