Lower riskDrug recall · FDA · Published September 19, 2022
Unichem 0.3mg Clonidine Tablets Recall: Risk of Wrong Strength
Unichem Pharmaceuticals USA recalls 0.3mg Clonidine Hydrochloride Tablets due to possible mix-up with 0.2mg strength. This could lead to incorrect dosing if used without medical supervision.
“Unichem 0.3mg Clonidine Tablets Recall: Risk of Wrong Strength.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34320-unichem-0-3mg-clonidine-tablets-recall-risk-of-wrong-strength. Based on FDA recall #D-1541-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1541-2022%22&limit=1).
The FDA announced on Sept. 19, 2022, that Unichem Pharmaceuticals USA Inc. is recalling Clonidine Hydrochloride Tablets, USP, 0.3 mg due to a product mix-up hazard. The recall involves 18,960 bottles distributed nationwide.
The hazard is a product mix-up where 0.2 mg strength Clonidine Hydrochloride Tablets, USP were found in a 100-count bottle labeled as 0.3 mg strength.
Context
GovInfoNow's records show Unichem Pharmaceuticals USA Inc. has 11 other recalls on record since July 30, 2015. Recent recalls include a busPIRone 5mg Tablets recall for subpotent drug risk on April 13, 2026, and Doxazosin 4mg Tablets recalled due to wrong ID imprint on Jan. 21, 2026. Other recent recalls of similar products include Teva Clonidine Transdermal System Recall (March 19, 2026), Annora Pharma Lacosamide Tablets Recall (June 4, 2026), and American Health Packaging Buprenorphine Tablets Recall (Aug. 19, 2026).
How to tell if you have this one
Check for the product name 'Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle' on the label. The NDC code is 29300-137-01 and lot number GCLH22005 (expiring 02/29/2024).
Brand
Unichem Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the NDC code 29300-137-01 and lot number GCLH22005 on the label to confirm it's the recalled item.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed 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 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
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-1541-2022 (September 19, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1541-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.