Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack — Class II drug recall D-1085-2015
Completed recall by Boehringer Ingelheim Roxane Inc, reported 2015-06-03, distributed nationwide. Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) a
| Recall number | D-1085-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Roxane Inc, Columbus, OH, United States |
| Recall initiated | 2015-04-02 |
| Classified | 2015-05-27 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2016-02-19 |
| Distributed | Nationwide (US) |
| Reason classes | potency, specification failure |
| NDC | 00054-0140, 00054-0140-25, 00054-0141, 00054-0141-20, 00054-0141-25, 00054-0142, 00054-0142-25 |
| Lot numbers | 460073A, 460073B |
| Expiration dates | 2016-04 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1085-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.