US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 18, 2018 (8 years ago)

Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.

What was recalled

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.

Recalling firm
Hetero Labs, Ltd. - Unit III
NDC code
31722-543-01
Origin
N/A, India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1019-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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