Class II U.S. Food and Drug Administration

Boehringer Ingelheim Pharmaceuticals, Inc. Synjardy XR Tablets , 12.5/1000 mg recall: CGMP Deviations: An incorrect detergent was used and the required swab

Recall published 4 months ago

CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

The hazard: Labelling or manufacturing-practice failure

The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

What the notice says: CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0657-2026
Published
July 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Boehringer Ingelheim Pharmaceuticals, Inc.
Product type
Prescription & OTC drugs
Units affected
560 bottles
Distribution
Ohio
Made in
United States
Lot / code info
Lot 3244413; Exp. 12/31/2028

Products covered by this recall

Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 3244413

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 12
  • 31
  • 2028 — 560 bottles

NDC number

On the carton and again on the bottle or blister label.

  • 00597-0300-45

Package size

Match the net weight or the piece count on the front of the pack.

  • 1000 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

Boehringer Ingelheim Pharmaceuticals, Inc. — The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.
  3. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.
  4. Keep taking the medicine as prescribed unless the notice or your prescriber says otherwise.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Boehringer Ingelheim Pharmaceuticals, Inc. — 900 Ridgebury Rd, Ridgefield, CT, 06877-1058

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Boehringer Ingelheim Pharmaceuticals, Inc. prescription &… recalled?

CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product. CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 3244413; best-by date 12 or 31. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Which states were affected?

The notice lists Ohio.

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