Direct Rx Nortriptyline 10mg Capsules Recall: Cgmp Deviations Risk
Direct Rx recalls 10mg Nortriptyline capsules due to manufacturing errors affecting ingredient quality. Affected lots may contain incorrect active ingredient levels.
Lower-risk recall
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
Contact the company
What happened, in plain English
Direct Rx is recalling 10mg Nortriptyline HCl capsules that were made with an incorrect ingredient batch. This could mean the medication has less active ingredient than labeled, potentially reducing effectiveness. Read more at govinfonow.com/recall/36496-direct-rx-nortriptyline-10mg-capsules-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36496-direct-rx-nortriptyline-10mg-capsules-recall-cgmp-deviations-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0300-2021
Cite this page
“Direct Rx Nortriptyline 10mg Capsules Recall: Cgmp Deviations Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36496-direct-rx-nortriptyline-10mg-capsules-recall-cgmp-deviations-risk. Based on FDA recall #D-0300-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0300-2021%22&limit=1).
Why it’s dangerous
The manufacturing process accidentally used an ingredient from a different supplier before it was officially approved. This could result in the capsules having less active medication than labeled, making the treatment less effective.
Who’s affected
Prescription users of Direct Rx Nortriptyline 10mg capsules with the specific lot number 28DE2002. Patients on this medication for depression or nerve pain are most at risk.
How to tell if you have this one
Check for the lot number 28DE2002 on the bottle. The product is a 30-count bottle of 10mg Nortriptyline HCl capsules, prescription-only, with NDC 6191985330.
- Brand
Direct Rx- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 28DE2002 on the bottle label to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed in Georgia.
FDA distribution: “GA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall is for potential reduced effectiveness, not immediate safety risks. The product may still be safe but less effective.
Similar recalls
Other Direct Rx recalls
Latest drug recalls
Keep exploring
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-0300-2021 (March 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0300-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.