Parsel Plus — Class II drug recall D-846-2013
Terminated recall by Novartis Consumer Health, reported 2013-08-14, distributed nationwide. Defective container: products are packaged in pouches which may not have been fully sealed
| Recall number | D-846-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Consumer Health, Lincoln, NE, United States |
| Recall initiated | 2013-06-06 |
| Classified | 2013-08-06 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2014-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, PA |
| Quantity | 472,000 pouches |
| Reason classes | packaging |
| Lot numbers | 10121996, 7/13 |
Product
Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm
Reason for recall
Defective container: products are packaged in pouches which may not have been fully sealed
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-846-2013. 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.