Skip to content
Get alerts
GovInfoNow
Lower risk Drug recall · FDA · Published March 9, 2023

JARDIANCE 25mg Tablets: Label Mix-Up Recall

Boehringer Ingelheim recalls JARDIANCE 25mg tablets due to potential label mix-up. Affected lots E61835 expire June 2025. Consumers should check packaging for correct labeling.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0468-2023DrugBoehringer Ingelheim ›
Take action

Contact the company

Recalling firmBoehringer Ingelheim Pharmaceuticals, Inc.900 Ridgebury Rd · Ridgefield, CT 06877-1058
✎ GovInfoNow plain-language explainer

Boehringer Ingelheim is recalling JARDIANCE 25mg tablets that may have incorrect labeling. This could lead to confusion about which product is being used, but it does not pose a direct health risk. Read more at govinfonow.com/recall/33826-jardiance-25mg-tablets-label-mix-up-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/33826-jardiance-25mg-tablets-label-mix-up-recall · Updated August 18, 2026 · FDA enforcement record: FDA #D-0468-2023

Cite this page

“JARDIANCE 25mg Tablets: Label Mix-Up Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33826-jardiance-25mg-tablets-label-mix-up-recall. Based on FDA recall #D-0468-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0468-2023%22&limit=1).

The FDA announced on March 9, 2023, that Boehringer Ingelheim Pharmaceuticals, Inc. voluntarily recalled JARDIANCE (Empagliflozin), 25 mg Tablets due to a labeling mix-up hazard. The recall affects 69,375 bottles distributed nationwide.

How to tell if you have it

  • JARDIANCE (Empagliflozin), 25 mg Tablets
  • NDC0597-0153-30 (30-count)
  • NDC 0597-0153-90 (90-count)
  • Lot #: E61835, exp. date JUN 2025

The hazard

The recall involves JARDIANCE tablets packaged in 30-count and 90-count bottles where the labeling was mixed up. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Boehringer Ingelheim Pharmaceuticals, Inc. has had 9 other recalls on record since 2016-10-06. Other recent recalls of similar products include Synjardy XR Tablets Recall (2026-06-12) and Boehringer Ingelheim Micardis Tablets 80mg Recall (2021-05-04). Other recent recalls of similar products include American Health Packaging Buprenorphine Tablets Recall (2026-08-19) and Sun Pharmaceutical Perampanel 6mg Tablets Recall (2026-06-17).

How to tell if you have this one

Check your JARDIANCE 25mg tablets for the lot number E61835 on the packaging. The product is sold in 30-count or 90-count bottles and expires June 2025.

  • Brand
    Boehringer Ingelheim
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Labeling

    Look for the lot number E61835 on the packaging of your JARDIANCE 25mg tablets.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Product was distributed nationwide within the United States and PR” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

1. Firm started the recall: Mar 9, 202312. FDA classified it Class II: Mar 17, 202323. Published in FDA’s Enforcement Report: Mar 29, 202334. FDA terminated the recall: Dec 4, 202342023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

American Health Packaging Buprenorphine Tablets Recall: Label Mix-Up Hazard
American Health PackagingSynjardy XR Tablets Recall: Incorrect Detergent Used in Manufacturing
Boehringer IngelheimUnichem Cyclobenzaprine Tablets Recalled Due to Label Mix-Up
UnichemAmerican Health Packaging Recalls Metoclopramide Tablets Due to Foreign Drug Presence
American Health PackagingTeva Recalls Metoclopramide Tablets Due to Foreign Contaminants
Teva Pharmaceuticals USA, Inc

Latest drug recalls

Preferred Pharmaceuticals, Inc. recalls Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A.,
Preferred Pharmaceuticals · September 28, 2026SUN PHARMACEUTICAL INDUSTRIES INC recalls Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro
Northstar Rx · September 25, 2026Apothecary Pharma LLC recalls Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary,
Apothecary Pharma · September 24, 2026Apotex Corp. recalls Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario,
Apotex · September 23, 2026Cipla USA, Inc. recalls Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx
Cipla USA · September 18, 2026Ajanta Pharma USA Inc recalls Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc.,
Ajanta Pharma · September 17, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0468-2023 (March 9, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0468-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA