Class III · Low risk
Tolterodine Tartrate Extended-Release Capsules
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Is Tolterodine recalled?
Not under an active recall.
Tolterodine was recalled 4 times in the past — all now closed. Most recent: Mar 4, 2025.
Most common reason: Labeling / mix-up (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tolterodine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Tolterodine recalls on record
none so far in 2026; 4 on record, newest first
Class III · Low risk
Tolterodine Tartrate Tablets
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Class II · Moderate risk
Tolterodine Tartrate ER
Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 4 mg may be potentially mislabeled as one of the following drugs: HYDRALAZINE HCL, Tablet, 25 mg, NDC 50111032701, Pedigree: AD49610_4, EXP: 5/16/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, 0 mg, NDC 51991056601, Pedigree: AD73597_1, EXP: 5/31/2014.
Class II · Moderate risk
Tolterodine Tartrate ER
Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 2 mg may be potentially mislabeled as one of the following drugs: RANOLAZINE ER , Tablet, 500 mg, NDC 61958100301, Pedigree: AD62995_7, EXP: 5/29/2014; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), NDC 00904759160, Pedigree: W002717, EXP: 6/6/2014.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.