June 2026 FDA Recall Drug by Boehringer Ingelheim Pharmaceuticals, Inc.
D-0657-2026 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Boehringer Ingelheim Pharmaceuticals, Inc. on June 12, 2026 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in OH and the recall is currently ongoing.

Recall Number: D-0657-2026

Reason for Recall
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.
Initiated
06-12-2026
Reported
07-08-2026
Quantity
560 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99233
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Boehringer Ingelheim Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
OH
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot 3244413; Exp. 12/31/2028