FDA Drug recall D-1085-2015
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc
- FDA Drug
- Class II
- completed
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc by Boehringer Ingelheim Roxane, citing subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1085-2015 |
| Classification | Class II |
| Status | completed |
| Initiated | 2015-04-02 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Boehringer Ingelheim Roxane |
| Distribution | US |
Product
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
Reason
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Identifiers
| ndc | 0054-0140-25 |
|---|---|
| ndc | 0054-0141-20 |
| ndc | 0054-0141-25 |
| ndc | 0054-0142-25 |
| code_info | a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1085-2015%22
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