Class II · Moderate risk
Lithium Carbonate Extended-Release Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Is Lithium recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Lithium (7 total). Check the affected lots below.
Most common reason: Labeling / mix-up (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lithium. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lithium recalls on record
none so far in 2026; 7 on record, newest first
Class II · Moderate risk
Lithium Carb 150mg 100
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Mineral Mix Schrader
Lack of Assurance of Sterility
Class II · Moderate risk
Lithium Carbonate ER
Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 300 mg may be potentially mislabled as the following drug: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD39588_10, EXP: 5/13/2014.
Class II · Moderate risk
Lithium Carbonate ER
Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 450 mg may be potentially mislabled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD21790_19, EXP: 5/1/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD46257_28, EXP: 5/15/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W002729, EXP: 6
Class II · Moderate risk
Lithium Carbonate ER
Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) may be potentially mislabled as one of the following drugs: CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD73525_7, EXP: 5/30/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD21846_11, EXP: 5/1/2014.
Class II · Moderate risk
Lithium Chloride 5mg/Ml Injectable 30 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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