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Boehringer Ingelheim Pharmaceuticals, Inc.

Check your batch

Check the batch codes below. If yours matches, return it for a refund rather than take it.

Class II

  • May cause temporary or medically reversible harm. Serious consequences are unlikely.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Check your batch Filed 2026-07-08

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.

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 these codes: Lot 3244413; Exp. 12/31/2028

560 bottles · distributed oh Recall D-0657-2026 on FDA.gov ↗
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