Unrated Drug recall · FDA · Published March 21, 2022

Sandoz Orphenadrine Tablets Recall: Nitrosamine Impurity Risk

Sandoz recalls 100-mg extended-release orphenadrine tablets with nitrosamine impurities above safe limits. Affected lots from 2022-2023 may pose health risks. Consumers should contact Sandoz for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0753-2022Drug Sandoz ›

Recall notice

CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.

Take action

Contact the company

Recalling firmSandoz, Inc506 Carnegie Ctr Ste 400 · Princeton, NJ 08540-6243

✎ GovInfoNow plain-language explainer

Sandoz is recalling certain orphenadrine citrate extended-release tablets due to nitrosamine impurities exceeding safe levels. This could pose health risks if taken as directed. The recall affects specific lots manufactured between 2022 and 2023. Read more at govinfonow.com/recall/35064-sandoz-orphenadrine-tablets-recall-nitrosamine-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35064-sandoz-orphenadrine-tablets-recall-nitrosamine-impurity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0753-2022

Cite this page

“Sandoz Orphenadrine Tablets Recall: Nitrosamine Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35064-sandoz-orphenadrine-tablets-recall-nitrosamine-impurity-risk. Based on FDA recall #D-0753-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0753-2022%22&limit=1).

The FDA announced on March 21, 2022, that Sandoz Inc. voluntarily recalled Orphenadrine Citrate Extended-Release Tablets due to nitrosamine impurity levels exceeding acceptable limits. The recall affects 790,800 tablets distributed nationwide.

How to tell if you have it

Brand: Sandoz
Product: Orphenadrine Citrate Extended-Release Tablets, USP 100 mg
NDC: 0185-0022-01
Lot codes and expiration dates: JX6411 (Exp. 05/2022), JX6413 (Exp. 05/2022), KC0723 (Exp. 08/2022), KC3303 (Exp. 08/2022), KE4348 (Exp. 11/2022), KE7169 (Exp. 11/2022), KE4349 (Exp. 11/2022), KL3199 (Exp. 03/2023), KM0072 (Exp. 03/2023), KS3939 (Exp. 03/2023), LA7704 (Exp. 11/2023), LA7703 (Exp. 11/2023), LA9243 (Exp. 11/2023)

The hazard

According to the FDA, the recall was initiated because of cGMP deviations resulting in nitrosamine impurity (NMOA) above the acceptable daily limit.

Context

GovInfoNow's records show Sandoz Inc. has had 29 other recalls on record since October 9, 2013. Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets Recall (August 5, 2026), Appco Pharma Prazosin Capsules Recall (March 27, 2026), and Alembic Fesoterodine Tablets Recall (December 16, 2025).

How to tell if you have this one

Check the lot numbers and expiration dates on the packaging: JX6411, JX6413 (exp 05/2022), KC0723, KC3303 (exp 08/2022), KE4348, KE7169, KE4349 (exp 11/2022), KL3199, KM0072, KS3939 (exp 03/2023), LA7704, LA7703, LA9243 (exp 11/2023).

Brand
Sandoz
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot numbers and expiration dates listed in the recall notice to confirm if your tablets are affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Mar 21, 2022Firm started the recall
Apr 6, 2022FDA classified it Class II
Apr 13, 2022Published in FDA’s Enforcement Report
Aug 14, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Sandoz recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/35064-sandoz-orphenadrine-tablets-recall-nitrosamine-impurity-risk">Sandoz Orphenadrine Tablets Recall: Nitrosamine Impurity Risk (GovInfoNow)</a>

Where this comes from

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-0753-2022 (March 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0753-2022 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.