Pain Reliever — Class II drug recall D-0765-2023
Completed recall by Aurobindo Pharma USA Inc., reported 2023-05-31, distributed nationwide. Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloratio
| Recall number | D-0765-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2023-05-22 |
| Classified | 2023-05-24 |
| Reported by FDA | 2023-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 87,360 bottles |
| Reason classes | specification failure |
| NDC | 00363-9947, 00363-9947-29, 00363-9947-35, 00363-9947-40 |
| Lot numbers | P2200101, P2200178, P2200230 |
| Expiration dates | 2023-11, 2023-12 |
Product
Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.
Reason for recall
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
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-0765-2023. 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.