Indomethacin Capsules — Class II drug recall D-1019-2018
Terminated recall by Hetero Labs, Ltd. - Unit III, reported 2018-08-08, distributed nationwide. Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck tog
| Recall number | D-1019-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hetero Labs, Ltd. - Unit III, Hyderabad, N/A, India |
| Recall initiated | 2018-07-18 |
| Classified | 2018-07-27 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2021-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 18,288 bottles |
| NDC | 31722-0542, 31722-0542-01, 31722-0542-05, 31722-0542-10, 31722-0542-30, 31722-0543, 31722-0543-01, 31722-0543-05, 31722-0543-10, 31722-0543-30 |
| Lot numbers | 12/19, E180315 |
Product
Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.
Reason for recall
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
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-1019-2018. 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.