Drugs & medicalClass III

Lupin Pharmaceuticals Inc. recalls Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451…

Subpotent Drug

Read the official notice →
Date
2021-12-08
Country
United States
Brand
Lupin Pharmaceuticals
Product
Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg),…
Classification
Class III
Units
nationwide within the United States
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Lupin Pharmaceuticals recalls

  1. 2022-05-11
  2. US
    Drugs & medicalClass II

    Lupin Pharmaceuticals Inc. recalls Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only,…

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    FDA · DrugLupin Pharmaceuticals Inc.Product was distributed nationwideOfficial notice →
  3. 2022-01-12
  4. US
    Drugs & medicalClass III

    Lupin Pharmaceuticals Inc. recalls Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore,…

    Out-of-specification impurity test result observed at 18-month long term stability time point.

    FDA · DrugLupin Pharmaceuticals Inc.Product Distributed in NY and OH.Official notice →
  5. US
    Drugs & medicalClass III

    Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC…

    Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.

    FDA · DrugLupin Pharmaceuticals Inc.Nationwide in the USA and Puerto RicoOfficial notice →
  6. 2021-11-10
  7. US
    Drugs & medicalClass II

    Lupin Pharmaceuticals Inc. recalls Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09)…

    CGMP Deviations: impurity N-nitrosoirbesartan detected in API

    FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to major distributors who may have further distributed…Official notice →
  8. 2021-11-03
  9. US
    Drugs & medicalClass III

    Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC…

    Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.

    FDA · DrugLupin Pharmaceuticals Inc.Nationwide in the USA and Puerto RicoOfficial notice →
  10. 2021-10-27
  11. US
    Drugs & medicalClass II

    Lupin Pharmaceuticals Inc. recalls Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…

    Out of specification result observed in a dissolution test at the 9-month long term stability time point.

    FDA · DrugLupin Pharmaceuticals Inc.Distributed Nationwide in the USA.Official notice →
All 38 Lupin Pharmaceuticals recalls →

Other drugs & medical recalls in the United States

  1. 2021-12-08
  2. US
  3. US
    Drugs & medicalClass I

    Sandoz Inc recalls Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only;…

    Temperature Abuse; temperature excursion during shipping

    FDA · DrugSandoz IncNationwide in the USOfficial notice →
  4. US
    Drugs & medicalClass II

    Pfizer Inc. recalls 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC…

    Lack of sterility assurance: bag has the potential to leak.

    FDA · DrugPfizer Inc.USA NationwideOfficial notice →
  5. US
  6. 2021-12-01
  7. US
    Drugs & medicalClass II

    Atrium Medical Corporation recalls The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds…

    Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient

    FDA · DeviceAtrium Medical CorporationUS Nationwide Distribution Foreign: Bahrain Belgium Brunei Darussalam Canada…Official notice →
  8. US
    Drugs & medicalClass II

    Becton Dickinson Infusion Therapy Systems Inc. recalls BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min…

    There is a breach in the product packaging that renders the product non-sterile.

    FDA · DeviceBecton Dickinson Infusion Therapy Systems Inc.U.S. Nationwide Distribution: AR, AZ, MA, GA, NC, OH, WA, NY, NJ, HI, CA, MD,…Official notice →
See all drugs & medical recalls →