Boehringer Ingelheim Roxane Perindopril Erbumine Tablets Recall

Why it was recalled

Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.

Product description

Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.

Lot numbers, UPCs & expiration codes

Lot #160017A, Exp 04/2013.

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-126-2013
Classification: Class III
Status: Terminated
Recall initiated: Dec 12, 2012
FDA report date: Jan 23, 2013
Quantity: 3,553 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Boehringer Ingelheim Roxane Inc

Original FDA data

Every field from FDA enforcement report D-126-2013, exactly as published.

Show all FDA fields

City: Columbus
State: OH
Status: Terminated
Country: United States
Event ID: 63952
Address: 1809 Wilson Rd
Code information: Lot #160017A, Exp 04/2013.
Postal code: 43228-9579
Report date: Jan 23, 2013
Product type: Drugs
Recall number: D-126-2013
Classification: Class III
Recalling firm: Boehringer Ingelheim Roxane Inc
Product quantity: 3,553 bottles
Termination date: Jun 16, 2014
Reason for recall: Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Distribution pattern: Nationwide
Recall initiation date: Dec 12, 2012
Initial firm notification: Letter
Center classification date: Jan 16, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-126-2013, published Jan 23, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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