Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Tizanidine recalled?

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.

Tizanidine recalls on record

none so far in 2026; 14 on record, newest first
Class II · Moderate risk

Tizanidine Tablets

Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.

Completed Particulate / foreign matter Dr. Reddy's Laboratories, Inc. NDC 55111-180-15 D-0223-2024
Class II · Moderate risk

Tizanidine Tablets

Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.

Terminated Dissolution failure Amerisource Health Services LLC NDC 68084-645-01 D-0892-2023
Class II · Moderate risk

Tizanidine Tablets USP

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Ongoing Dissolution failure Dr Reddy's Laboratories Limited NDC 55111-180-10 D-0923-2023
Class II · Moderate risk

Tizanidine HCl Tablets

Failed Tablet/Capsule Specification: Some tablets are shaved

Terminated Failed specification Dr. Reddy's Laboratories, Inc. NDC 55111-180-15 D-0750-2021
Class II · Moderate risk

Tizanidine Tablets

Failed Dissolution Specifications; Out of Specification (low) results were obtained.

Terminated Dissolution failure Ascend Laboratories LLC D-0173-2021
Class II · Moderate risk

Tizanidine HCl Tablets

Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .

Terminated Particulate / foreign matter Dr. Reddy's Laboratories, Inc. NDC 55111-179-15 D-1191-2018
Class II · Moderate risk

Tizanidine HCl active pharmaceutical ingredient packaged in…

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.

Terminated Cross-contamination Attix Pharmaceuticals D-931-2015
Class II · Moderate risk

tiZANidine HCl

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.

Terminated Labeling / mix-up Aidapak Services, LLC D-893-2014
Class II · Moderate risk

tiZANidine HCL Tablet

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.

Terminated Labeling / mix-up Aidapak Services, LLC D-627-2014
Class II · Moderate risk

tiZANidine HCl Tablet

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

Terminated Labeling / mix-up Aidapak Services, LLC D-621-2014
Class II · Moderate risk

tiZANidine HCl Tablet

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.

Terminated Labeling / mix-up Aidapak Services, LLC D-620-2014
Class III · Low risk

Tizanidine Tablets USP

Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.

Terminated Labeling / mix-up Dr. Reddy'S Laboratories NDC 55111-180-15 D-238-2013
Class III · Low risk

Tizanidine

Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.

Terminated Labeling / mix-up Stat Rx USA NDC 16590-221-90 D-1427-2012