PROMETHAZINE HYDROCHLORIDE Tablets — Class II drug recall D-1342-2014
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2014-05-28, distributed nationwide. Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
| Recall number | D-1342-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2014-05-08 |
| Classified | 2014-05-21 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2016-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 10,200 bottles |
| NDC | 68382-0040, 68382-0040-01, 68382-0040-05, 68382-0040-10, 68382-0041, 68382-0041-01, 68382-0041-05, 68382-0041-10, 68382-0042, 68382-0042-01, 68382-0042-05, 68382-0042-10 |
| Lot numbers | MN9081 |
| Expiration dates | 2015-09 |
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 for recall
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
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-1342-2014. 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.