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

Lithium Carbonate Extended-Release Tablets

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.

Other Carbonate recalls

See all
Class II · Moderate risk Ongoing

TopCare health

Reason Presence of foreign substance: small metallic particles in chewable tablets.

Guardian Drug Co. Inc. NDC 76162-129-68 D-0579-2026
Class II · Moderate risk Ongoing

TopCare health

Reason Presence of foreign substance: small metallic particles in chewable tablets.

Guardian Drug Co. Inc. NDC 76162-128-22 D-0578-2026
Class II · Moderate risk Ongoing

EQUALINE ultra strength

Reason Presence of foreign substance: small metallic particles in chewable tablets.

Guardian Drug Co. Inc. NDC 41163-171-68 D-0577-2026
Class II · Moderate risk Ongoing

EQUALINE extra strength

Reason Presence of foreign substance: small metallic particles in chewable tablets.

Guardian Drug Co. Inc. NDC 41163-129-22 D-0576-2026
Class II · Moderate risk Ongoing

GOODSENSE Ultra Strength

Reason Presence of foreign substance: small metallic particles in chewable tablets.

Guardian Drug Co. Inc. NDC 50804-171-68 D-0575-2026