Ranolazine Extended-Release Tablets 1000mg
CGMP Deviations
Yes — there is an active recall. 2 ongoing FDA recalls mention Ranolazine (3 total). Check the affected lots below.
Most common reason: cGMP deviation (1 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ranolazine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations
Failed Dissolution Specifications: Out of specification for dissolution.
Labeling:Label Mixup; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD25452_16, EXP: 5/3/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD70585_16, EXP: 5/29/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W002852, EXP: 6/7/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree:
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