Tizanidine recalls: 8 FDA reports
Recalls involving Tizanidine. What was wrong with each batch, and how the FDA graded the risk.
8Reports
0Class I
2Ongoing
2024-01-17Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam
D-0223-2024 · Class II · reported 2024-01-17 · Completed
- Why it was recalled
- Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
- Product
- Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15
- Where it went
- USA Nationwide
- How much
- 38,952 bottles
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Sri
D-0923-2023 · Class II · reported 2023-07-26 · Ongoing
- Why it was recalled
- Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
- Product
- Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
- Where it went
- Nationwide in the USA
- How much
- 17,548 1000-countbottles
Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (N
D-0894-2023 · Class II · reported 2023-07-12 · Ongoing
- Why it was recalled
- Failed Stability Specifications
- Product
- Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.
- Where it went
- Nationwide within the United States
- How much
- 541 Bottles
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Pack
D-0892-2023 · Class II · reported 2023-07-12 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
- Product
- Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.
- Where it went
- Nationwide in the USA
- How much
- 4,971 cartons
Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikak
D-0750-2021 · Class II · reported 2021-08-25 · Terminated
- Why it was recalled
- Failed Tablet/Capsule Specification: Some tablets are shaved
- Product
- Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.
- Where it went
- Nationwide within the United States
- How much
- 37560 bottles
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai -
D-0173-2021 · Class II · reported 2020-12-09 · Terminated
- Why it was recalled
- Failed Dissolution Specifications; Out of Specification (low) results were obtained.
- Product
- Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.
- Where it went
- MI
- How much
- 1200 bottles
Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilaku
D-1191-2018 · Class II · reported 2018-09-26 · Terminated
- Why it was recalled
- Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
- Product
- Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153
- Where it went
- Nationwide within the United States
- How much
- 8376 units
Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited
D-238-2013 · Class III · reported 2013-04-10 · Terminated
- Why it was recalled
- Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
- Product
- Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.
- Where it went
- Nationwide and Puerto Rico.
- How much
- 117,546 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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