Tizanidine Tablets
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Yes — there is an active recall. 2 ongoing FDA recalls mention Tizanidine (14 total). Check the affected lots below.
Most common reason: Labeling / mix-up (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tizanidine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Failed Stability Specifications
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Failed Tablet/Capsule Specification: Some tablets are shaved
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Labeling: Label Mixup: tiZANidine HCl, Tablet, 2 mg may have potentially been mislabeled as the following drug: NIACIN TR, Tablet, 500 mg, NDC 00904434260, Pedigree: W002969, EXP: 6/11/2014.
Labeling:Label Mixup; tiZANidine HCL Tablet, 2 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD70700_4, EXP: 5/29/2014; NIFEdipine ER, Tablet, 60 mg, NDC 00591319401, Pedigree: W003729, EXP: 6/26/2014.
Labeling:Label Mixup; tiZANidine HCl Tablet, 2 mg may be potentially mislabeled as RIBAVIRIN, Capsule, 200 mg, NDC 68382026007, Pedigree: AD21790_37, EXP: 4/30/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD46257_59, EXP: 5/15/2014; NIACIN, Tablet, 100 mg, NDC 00904227160, Pedigree: W002661, EXP: 6/5/2014; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 00008060601, Pedigree
Labeling:Label Mixup; tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD60428_10, EXP: 5/22/2014.
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
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