Boehringer Ingelheim recalls Synjardy XR tablets due to potential contamination from incorrect detergent use during production. Affected lots may have unsafe levels of impurities.
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.
Boehringer Ingelheim is recalling Synjardy XR tablets (12.5/1000 mg) because manufacturing errors could have left harmful impurities. This affects people prescribed this diabetes medication who have the specific lot numbers listed in the recall.
The recall is due to manufacturing errors where an incorrect detergent was used and required swab sampling was skipped on a production hopper that had previously been used for another product. This could lead to impurities in the tablets that might not be safe for consumption.
People with diabetes prescribed Synjardy XR tablets who have the specific lot number 3244413 and expiration date 12/31/2028 are affected. Those using the medication without a prescription are not at risk.
Check the product label for the lot number 3244413 and expiration date 12/31/2028. The tablets are prescription-only and come in 60-count bottles with the NDC code 00597-0300-45.
Look for the lot number 3244413 and expiration date 12/31/2028 on the tablet packaging.
The recall does not state that the medication is unsafe to take; it indicates potential manufacturing errors that could lead to impurities. Consult your doctor for advice.
The recall record does not specify a remedy, so there is no action required beyond checking your product label for the affected lot number.
Check the product label for the lot number 3244413 and expiration date 12/31/2028. The NDC code 00597-0300-45 is also listed for identification.
We’ve drafted a message you can send Boehringer Ingelheim to request your refund or repair — edit it as you like.
Subject: Recall D-0657-2026 — Boehringer Ingelheim Boehringer Ingelheim Hello, I own a Boehringer Ingelheim that is covered by recall D-0657-2026 from Boehringer Ingelheim. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
