Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer — Class III drug recall D-0665-2021
Terminated recall by LNK International, Inc., reported 2021-07-28. Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not
| Recall number | D-0665-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LNK International, Inc., Hauppauge, NY, United States |
| Recall initiated | 2021-07-07 |
| Classified | 2021-07-16 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2023-05-04 |
| Quantity | 8,472 bottles |
| Reason classes | labeling |
| NDC | 46122-0649-71 |
| Lot numbers | P120999 |
| Expiration dates | 2022-07-31 |
Product
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71
Reason for recall
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
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-0665-2021. 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.