ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets — Class I drug recall D-0663-2016
Terminated recall by Medline Industries Inc, reported 2016-02-24, distributed nationwide. Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to cont
| Recall number | D-0663-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Mundelein, IL, United States |
| Recall initiated | 2015-09-25 |
| Classified | 2016-02-12 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2016-06-29 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| NDC | 53329-0642-30 |
| Lot numbers | 05/18, 45810 |
Product
ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30.
Reason for recall
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg 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-0663-2016. 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.