FDA Drug recall D-1019-2018
Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854
- FDA Drug
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 by Hetero Labs Unit Iii, citing failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1019-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-18 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hetero Labs Unit Iii |
| Distribution | US |
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
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Identifiers
| ndc | 31722-542-30 |
|---|---|
| ndc | 31722-542-01 |
| ndc | 31722-542-05 |
| ndc | 31722-542-10 |
| ndc | 31722-543-30 |
| ndc | 31722-543-01 |
| ndc | 31722-543-05 |
| ndc | 31722-543-10 |
| code_info | Lot #: E180315, Exp 12/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1019-2018%22
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