FDA Drug recall D-0665-2021
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Berg…
- FDA Drug
- Class III
- terminated
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class III recall of Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Berg… by Lnk International, citing 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'.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0665-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-07-07 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lnk International |
| Distribution | PA |
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
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'
Identifiers
| code_info | Lot # P120999, Exp 07/31/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class III · 2022-10-26 · Lnk International - Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Dr…
FDA Drug · Class III · 2022-09-07 · Lnk International - Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart St…
FDA Drug · Class II · 2019-08-07 · Lnk International - Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed…
FDA Drug · Class II · 2014-12-31 · Lnk International
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0665-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.