The Recall Desk

Hazard

Dosage Error recalls

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

What the numbers show

Total
45
Critical
7
Severe
19
Most recent
2025-03-19

Of the 45 dosage error recalls we have scored against our rubric, 7 (16%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (42%) 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 dosage error 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.

26–45 of 45

  • SevereFDA (Drugs)·D-0233-2018·2018-01-31

    Pravastatin Sodium Tablets Recalled Due to Foreign Tablet Presence

    International Laboratories, Inc. is recalling Pravastatin Sodium Tablets 10 mg because bottles may contain 20 mg tablets.

    Product
    Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1134-2017·2017-09-20

    Ascend Amlodipine Besylate Tablets Recalled for Foreign Tablet Presence

    Ascend Laboratories is recalling 10 mg Amlodipine Besylate tablets because 2.5 mg tablets were found mixed in the bottles.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1111-2017·2017-08-30

    Phenobarbital Tablets Recalled Due to Incorrect Strength Labeling

    C. O. Truxton is recalling Phenobarbital 15 mg tablets that were actually 30 mg due to a labeling error.

    Product
    Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0880-2017·2017-06-07

    Saphris Asenapine Tablets Recalled for Labeling Mixup

    Forest Laboratories is recalling Saphris (asenapine) sublingual tablets because blister packs labeled as 10 mg actually contain 5 mg tablets.

    Product
    SAPHRIS — SAPHRIS (ASENAPINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0215-2017·2016-12-28

    Impax Recalls Lamotrigine Tablets Due to Labeling Mixup

    Impax Laboratories is recalling 3,074 boxes of Lamotrigine Orally Disintegrating Tablets because some 200 mg boxes contained 100 mg tablets.

    Product
    Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0113-2017·2016-11-02

    Persantine Tablets Recalled Due to Presence of Foreign 50 mg Tablets

    Boehringer Ingelheim is recalling 2,562 bottles of 75 mg Persantine tablets because 50 mg tablets were found inside the bottles.

    Product
    Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0662-2016·2016-02-24

    Medline Recalls Mislabeled Acetaminophen Extra-Strength Pain Reliever Tablets

    Medline Industries is recalling 500 mg acetaminophen tablets mislabeled as 325 mg. Consumers should stop using the product and return it to the retailer.

    Product
    ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0663-2016·2016-02-24

    Medline Acetaminophen Tablets Recalled for Incorrect Strength Labeling

    Medline Industries is recalling 325 mg acetaminophen tablets that are actually 500 mg due to a labeling error.

    Product
    ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0007-2016·2015-10-14

    Merck Recalls Vytorin Tablets Due to Foreign Tablet Presence

    Merck Sharp & Dohme is recalling specific bottles of Vytorin 10 mg/20 mg tablets because they contain 10 mg/40 mg tablets. The recall affects distribution in Kentucky, Mississippi, and Ohio.

    Product
    Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only, 1000 count Bottle, Manuf. For Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, NDC 66582-0312-82.
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-0422-2015·2014-12-03

    Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access

    Hospira is recalling GemStar infusion pumps because patients are accessing dosage reset codes to change infusion rates set by doctors.

    Product
    GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2015·2014-12-03

    Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access

    Hospira Inc. is recalling GemStar infusion pumps because patients are using publicly available codes to change infusion rates set by doctors.

    Product
    GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1086-2014·2014-03-05

    Ranbaxy Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence

    Ranbaxy Inc. is recalling 64,626 bottles of Atorvastatin Calcium 10 mg tablets because a 20 mg tablet was found inside a sealed 10 mg bottle.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66447-001·2013-11-13

    Irinotecan Hydrochloride Injection Recalled for Incorrect Formulation Calculation

    West-Ward Pharmaceutical Corp. is recalling Irinotecan Hydrochloride Injection because a calculation error resulted in drug levels higher than labeled.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-057-2013·2012-11-28

    Qualitest Recalls Hydrocodone and Acetaminophen Tablets Due to Oversized Pills

    Vintage Pharmaceuticals is recalling 14,445 bottles of hydrocodone and acetaminophen tablets because confirmed complaints found oversized pills with superpotent drug levels.

    Product
    HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-058-2013·2012-11-28

    Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Superpotent Risk

    Watson Laboratories is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen tablets because they may be oversized and superpotent.

    Product
    Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-060-2013·2012-11-28

    Ranbaxy Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence

    Ranbaxy Inc. is recalling 32,208 bottles of Atorvastatin Calcium 10 mg tablets because a 20 mg tablet was found inside a sealed 10 mg bottle.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-020-2013·2012-10-31

    Hospira Recalls Overfilled Hydromorphone Hydrochloride Injection Cartridges

    Hospira is recalling 216,880 units of Hydromorphone Hydrochloride Injection because the prefilled cartridges were found to be overfilled, containing more than the labeled 1 mL volume.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-012-2013·2012-10-31

    Bristol-Myers Squibb Recalls BiCNU Injection Kits Due to Overfilled Vials

    Bristol-Myers Squibb is recalling 31,481 BiCNU kits nationwide and in Puerto Rico because stability testing revealed an overfilled vial in a single lot.

    Product
    BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Diluent manufactured by: Luitpold Pharmaceuticals, Inc. Shirley, NY 11967 Distributed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1444-2012·2012-08-15

    Hospira Recalls Overfilled Hydromorphone Hydrochloride Prefilled Cartridges

    Hospira Inc. is recalling 223,750 units of Hydromorphone Hydrochloride Injection because some prefilled cartridges contain more than the labeled 1 mL volume.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide