FDA Drug recall D-1032-2016
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals…
- FDA Drug
- Class III
- terminated
- Published 2016-06-22
On 2016-06-22 the FDA classified a Class III recall of Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals… by Valeant Pharmaceuticals North America, citing labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoep….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1032-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-05-23 |
| Published | 2016-06-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Valeant Pharmaceuticals North America |
| Distribution | US |
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
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.
Identifiers
| upc | 000950860068 |
|---|---|
| code_info | Lot #'s P0230-022R, P0230-023R, Exp 06/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1032-2016%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.