Synjardy XR Tablets Recall Issued
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Boehringer Ingelheim Pharmaceuticals, Inc. is recalling 560 bottles of Synjardy XR Tablets due to CGMP deviations involving incorrect detergent use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 6, 2026 and geographically references Ohio. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Boehringer Ingelheim Pharmaceuticals, Inc. initiated a voluntary recall due to 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.
Which Products Are Affected
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only. NDC: 00597-0300-45. Lot 3244413; Exp. 12/31/2028. 560 bottles distributed to OH.
What You Should Do
Consumers should verify product details against the lot and expiration information provided in the recall.
Why This Matters
The Class II recall affects a limited quantity of prescription diabetes medication distributed in Ohio.
Source
FDA recall D-0657-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (878 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.