FDA Drug recall D-1342-2014
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only by Zydus Pharmaceuticals Usa, citing presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1342-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-08 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01
Reason
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Identifiers
| ndc | 68382-040-01 |
|---|---|
| ndc | 68382-040-05 |
| ndc | 68382-040-10 |
| ndc | 68382-041-01 |
| ndc | 68382-041-05 |
| ndc | 68382-041-10 |
| ndc | 68382-042-01 |
| ndc | 68382-042-05 |
| ndc | 68382-042-10 |
| code_info | Lot #: MN9081, Expiry: 09/2015 |
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-1342-2014%22
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