Acetaminophen Tablets — Class II drug recall D-0471-2025
Ongoing recall by Aurobindo Pharma USA Inc, reported 2025-06-25, distributed nationwide. cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (b
| Recall number | D-0471-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc, East Windsor, NJ, United States |
| Recall initiated | 2025-05-22 |
| Classified | 2025-06-17 |
| Reported by FDA | 2025-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 4,608 bottles |
| Reason classes | cgmp |
| NDC | 72288-0405, 72288-0405-10 |
| Lot numbers | AEF124004A |
| Expiration dates | 2026-08-31 |
Product
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
Reason for recall
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
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-0471-2025. 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.