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.

1–25 of 45

  • SevereFDA (Drugs)·D-0268-2025·2025-03-19

    Potassium Chloride Injection Strength Mislabeled on Packaging Overwrap

    ICU Medical recalls Potassium Chloride Injection (lot 1023172) whose overwrap labeled as 10 mEq may contain 20 mEq containers, creating overdose risk. Product distributed nationwide.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0538-2024·2024-06-12

    Cephalexin Oral Suspension Recalled for Incorrect Dosage Label

    Bryant Ranch Prepack is recalling Cephalexin oral suspension because the back label incorrectly states the bottle contains 5g instead of 10g. No illnesses have been reported.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0279-2024·2024-02-07

    Phenylephrine IV Bags Recalled for Double-Dose Filling System Malfunction

    Denver Solutions is recalling 29,016 Phenylephrine HCl IV bags distributed nationwide. A filling system malfunction can result in some bags receiving double doses of this potent injectable drug.

    Product
    PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0280-2022·2021-12-22

    Lidocaine Topical Solution Recalled for Superpotency

    Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP 4% nationwide due to the drug being superpotent. Affected lots are 13262 (Exp. 03/2022) and 14217 (Exp. 08/2022).

    Product
    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0303-2021·2021-03-24

    Spironolactone Tablets Recalled Due to Potential Labeling Error

    Bryant Ranch Prepack is recalling 35 bottles of Spironolactone 25 mg tablets because they may contain 50 mg tablets.

    Product
    Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch P
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2021·2020-12-02

    Eywa Pharma Recalls Levetiracetam Tablets Due to Foreign Tablet Presence

    Eywa Pharma Inc. is recalling 500 mg Levetiracetam tablets because a 1000 mg tablet was found in a 500 mg bottle.

    Product
    Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1508-2020·2020-08-26

    Lannett Recalls Prednisone Tablets Due to Labeling Error

    Lannett Company, Inc. is recalling specific batches of Prednisone Tablets due to a labeling error where 2.5 mg bottles contained 10 mg tablets.

    Product
    Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 052
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1413-2020·2020-08-05

    Lupin Recalls Lisinopril Tablets Due to Foreign Tablet Presence

    Lupin Pharmaceuticals is recalling specific bottles of 10 mg Lisinopril tablets because 20 mg tablets were found inside. Consumers should stop using the affected product.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1341-2020·2020-07-01

    Alembic Recalls Aripiprazole Tablets Due to Labeling Error

    Alembic Pharmaceuticals is recalling aripiprazole tablets because bottles labeled as 2 mg contained 5 mg tablets. The error affects 19,153 bottles distributed nationwide.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1298-2020·2020-06-10

    Acella Recalls Superpotent NP Thyroid 15 Tablets Nationwide

    Acella Pharmaceuticals is voluntarily recalling 112,140 bottles of NP Thyroid 15 tablets because the drug is superpotent. The recall covers distribution across the US and Puerto Rico.

    Product
    NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1287-2020·2020-06-10

    Teva Recalls Mixed Amphetamine Salts Tablets Due to Mixed Strengths

    Teva Pharmaceuticals USA is recalling 84,209 bottles of 20 mg Mixed Amphetamine Salts tablets because some bottles may contain mixed strengths.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1079-2020·2020-04-08

    Lupin Recalls Lisinopril Tablets Due to Foreign Tablet Mix-Up

    Lupin Pharmaceuticals is recalling 25,944 bottles of Lisinopril 30 mg tablets because a 5 mg tablet was found mixed into a 30 mg bottle.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0647-2020·2020-01-08

    Akorn Recalls Myorisan 20mg Capsules Due to Mispackaging Error

    Akorn, Inc. is recalling Myorisan (isotretinoin) 20mg capsules because some cartons contained 40mg blister cards. The error was found in a customer complaint.

    Product
    MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0135-2020·2019-10-16

    Epic Pharma Recalls Estradiol Tablets Due to Foreign Tablet Presence

    Epic Pharma is recalling Estradiol 0.5 mg tablets because 1 mg tablets were found in the bottles. Patients should stop using the product and contact their healthcare provider.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1294-2019·2019-05-29

    Mallinckrodt Recalls Amitiza Capsules Due to Labeling Mix-Up

    Mallinckrodt Pharmaceuticals is recalling Amitiza (lubiprostone) capsules because 8 mcg and 24 mcg bottles were found with incorrect contents.

    Product
    AMITIZA — AMITIZA (LUBIPROSTONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1277-2019·2019-05-15

    Alvogen Recalls Fentanyl Transdermal Systems Due to Product Mix-Up

    Alvogen is recalling Fentanyl Transdermal Systems because a customer reported a carton labeled 12 mcg/h contained 50 mcg/h patches.

    Product
    FENTANYL SYSTEM — FENTANYL SYSTEM (FENTANYL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0386-2019·2019-01-30

    Bound Tree Medical Recalls Curaplex Epi Kits Due to Incorrect Instructions

    Bound Tree Medical is recalling 339 Curaplex Epi Kits because the instructions recommend an unapproved epinephrine dosage for young children.

    Product
    Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle, 25 ga x5/8 , 2 Vials of epinephrine, 1mg/1mL, 4 Alcohol prep pads, 2 Adhesive bandages, 1 x 3 1 Epi Generic Injection. Rx Only. Distributed by Sarnova HC, L
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0337-2019·2018-12-26

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of Infants' Ibuprofen because they may contain a higher concentration of the active ingredient.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0335-2019·2018-12-26

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of infants' ibuprofen oral suspension because they may contain a higher concentration of the active ingredient.

    Product
    infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0875-2018·2018-06-20

    Allergan Recalls Taytulla Contraceptive Softgels Due to Out-of-Sequence Tablets

    Allergan is recalling Taytulla softgel capsules because the tablets are out of sequence. This affects 168,768 blister cards distributed nationwide.

    Product
    TAYTULLA — TAYTULLA (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0826-2018·2018-05-30

    Exela Pharma Recalls Diclofenac and Misoprostol Tablets Due to Labeling Error

    Exela Pharma Sciences LLC is recalling 5,256 bottles of Diclofenac Sodium and Misoprostol tablets because some bottles were mislabeled with the wrong dosage.

    Product
    Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0804-2018·2018-05-09

    Sanofi Recalls Over-Concentrated Docetaxel Injection Vials Nationwide

    Sanofi-Aventis is recalling 19,580 vials of Docetaxel injection concentrate due to potential over-concentration. The affected lots were distributed nationwide.

    Product
    DOCETAXEL — DOCETAXEL (DOCETAXEL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0234-2018·2018-01-31

    International Laboratories Recalls Pravastatin Sodium Tablets Due to Foreign Tablets

    International Laboratories, Inc. is recalling Pravastatin Sodium Tablets, 20 mg, because bottles may contain 10 mg tablets. Patients should contact their healthcare provider.

    Product
    Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser carton, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16.
    Category
    Drug
    Distribution
    Distributed nationwide