US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jan 26, 2022 (5 years ago)

Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only…

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

Why it was recalled

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

What was recalled

Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01

Recalling firm
Cardinal Healthcare
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0189-2024

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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