Azathioprine Tablets USP — Class III drug recall D-1313-2014
Terminated recall by Boehringer Ingelheim Roxane Inc, reported 2014-05-14, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was giv
| Recall number | D-1313-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Roxane Inc, Columbus, OH, United States |
| Recall initiated | 2014-04-04 |
| Classified | 2014-05-06 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2015-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 8,304 bottles |
| Reason classes | labeling |
| NDC | 00054-4084-25 |
| Lot numbers | 11/15, 261983A |
Product
Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
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-1313-2014. 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.