Amerisource Health Services recalls Tizanidine 4mg tablets due to failed dissolution specifications. This repackaged product may not dissolve properly as tested, potentially affecting medication effectiveness.
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Take action
Contact the company
📍Recalling firmAmerisource Health Services LLC2550 John Glenn Ave Ste A · Columbus, OH 43217-1188
“Tizanidine 4mg Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33403-tizanidine-4mg-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0892-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0892-2023%22&limit=1).
Amerisource Health Services LLC recalled Tizanidine Tablets, USP, 4 mg on June 23, 2023, due to failed dissolution specifications, the FDA said. The agency announced the Class II recall of 4,971 cartons distributed nationwide.
How to tell if you have it
Brand: Amerisource Health Services
Product: Tizanidine Tablets, USP, 4 mg
Quantity: 100 Tablets (10 tablets x 10 unit dose blister packs) per carton
NDC: 68084-645-01
Barcode: 003 68084 645 11 2
Lot Code: 1004835
Expiration Date: 7/31/2023
Distributor: American Health Packaging, Columbus, Ohio 43217
The hazard
The repackaged product was recalled due to out-of-specification results for dissolution. The manufacturer, Dr. Reddy's Laboratories, Inc., initiated the voluntary recall.
Context
GovInfoNow's records show Amerisource Health Services LLC has 30 other recalls on record since July 27, 2022. Other recent recalls include a May 1, 2026 Primidone Tablets recall for cross-contamination risk and a March 16, 2026 Meclizine 12.5mg Tablets recall for failed tablet specifications. Similar products have faced issues, including Viatris Xanax XR 3mg Tablets recalled on March 17, 2026, for failed dissolution specifications and Sun Pharmaceutical Lisdexamfetamine Capsules recalled on October 28, 2025, for a failed dissolution test.
How to tell if you have this one
Look for Tizanidine 4mg tablets in 100-count blister packs with NDC 68084-645-01, lot 1004835, expiring July 31, 2023. The product was distributed by American Health Packaging in Columbus, Ohio.
Brand
Amerisource Health Services
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the NDC code 68084-645-01, lot number 1004835, and expiration date of July 31, 2023 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0892-2023 (June 23, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0892-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.