CLASS II Drug recall · Reported 3 Jun 2015 · FDA Enforcement Report
Acarbose Tablets 50 mg a) Unit Dose Tablets per, b) recalled
Boehringer Ingelheim Roxane is recalling Acarbose Tablets 50 mg a) Unit Dose Tablets per, b), distributed nationwide in the US. The recall was initiated on 2 Apr 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1085-2015
- FDA event ID
- 70990
- Recalling firm
- Boehringer Ingelheim Roxane, Columbus, OH
- Brand
- Acarbose
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 2 Apr 2015
- FDA classified
- 27 May 2015
- Reported
- 3 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 2 Apr 2015 | Recall initiated by company | |
| 27 May 2015 | Classified by FDA | +55 days |
| 3 Jun 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Which lots are affected?
a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Boehringer Ingelheim Roxane
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Furosemide Tablets USP, 20 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Combivent Respimat (ipratropium bromide recalledCombivent Respimat | Boehringer Ingelheim Roxane | Other | Nationwide |
| Drug | CLASS III | Oxycodone Hydrochloride C II Oral Solution USP, 5 mg/ Vial recalled | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcitriol Oral Solution 1 mcg/mL recalledCalcitriol | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
Other Acarbose recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acarbose Tablets, 25 mg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Acarbose, Tablet, 25 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Acarbose, Tablet 25 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |