Assured Aspirin Enteric Safety Coated Tablets — Class II drug recall D-0040-2015
Terminated recall by American Family Pharmacy, LLC, reported 2014-10-29, distributed in CA, VA, WA. Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.
| Recall number | D-0040-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Family Pharmacy, LLC, Indianapolis, IN, United States |
| Recall initiated | 2014-09-15 |
| Classified | 2014-10-21 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-09-25 |
| Distributed | CA, VA, WA |
| Quantity | 4,207,200 tablets |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 00639277018328 |
| Lot numbers | 05/16, 12084 |
Product
Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.
Reason for recall
Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.
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-0040-2015. 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.