Lodrane D — Class III drug recall D-1032-2016
Terminated recall by Valeant Pharmaceuticals North America LLC, reported 2016-06-22, distributed nationwide. Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled wi
| Recall number | D-1032-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, United States |
| Recall initiated | 2016-05-23 |
| Classified | 2016-06-15 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-09-12 |
| Distributed | Nationwide (US) |
| Quantity | 3,827 bottles |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00000950860068 |
| Lot numbers | 06/17, P0230-022R, P0230-023R |
Product
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8.
Reason for recall
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
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-1032-2016. 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.