Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack Recalled by Boehringer Ingelheim Roxane Inc Due to Subpotent Drug: The firm received an out of...

Date: April 2, 2015
Company: Boehringer Ingelheim Roxane Inc
Status: Completed
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Boehringer Ingelheim Roxane Inc directly.

Affected Products

Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25

Quantity: a) 575 Blister Packs, b) 12,802 Bottles

Why Was This Recalled?

Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Boehringer Ingelheim Roxane Inc

Boehringer Ingelheim Roxane Inc has 15 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report