Rizatriptan Benzoate Film Coated Tablets — Class III drug recall D-0078-2022
Terminated recall by MACLEODS PHARMA USA, INC, reported 2021-11-03, distributed nationwide. Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
| Recall number | D-0078-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MACLEODS PHARMA USA, INC, Princeton, NJ, United States |
| Recall initiated | 2021-10-18 |
| Classified | 2021-10-28 |
| Reported by FDA | 2021-11-03 |
| Terminated | 2024-04-24 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 33342-0087, 33342-0087-02, 33342-0087-07, 33342-0087-12, 33342-0087-41, 33342-0087-45, 33342-0087-46, 33342-0087-50, 33342-0087-52, 33342-0087-72, 33342-0088, 33342-0088-02, 33342-0088-07, 33342-0088-12, 33342-0088-41, 33342-0088-45, 33342-0088-46, 33342-0088-50, 33342-0088-52, 33342-0088-72 |
| Lot numbers | BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B |
| Expiration dates | 2024-04 |
Product
Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
Reason for recall
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
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-0078-2022. 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.