Taro Nortriptyline Capsules Recall: CGMP Deviations Risk
Taro Pharmaceuticals recalls 10mg Nortriptyline capsules made in Israel with CGMP deviations. Consumers should check NDC 51672-4001-1 for affected units. No specific remedy provided in recall notice.
Recall notice
CGMP deviations.
Contact the company
What happened, in plain English
Taro Pharmaceuticals is recalling 10mg Nortriptyline capsules produced in Israel due to manufacturing quality control issues. This recall does not specify a safety risk or required action for consumers. Read more at govinfonow.com/recall/36553-taro-nortriptyline-capsules-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36553-taro-nortriptyline-capsules-recall-cgmp-deviations-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0246-2021
Cite this page
“Taro Nortriptyline Capsules Recall: CGMP Deviations Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36553-taro-nortriptyline-capsules-recall-cgmp-deviations-risk. Based on FDA recall #D-0246-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0246-2021%22&limit=1).
Why it’s dangerous
The recall is based on CGMP (Current Good Manufacturing Practice) deviations during production. CGMP deviations can lead to inconsistent drug quality, but the specific risk to consumers is not detailed in this recall notice.
Who’s affected
People who purchased the recalled Nortriptyline capsules from Taro Pharmaceuticals U.S.A., Inc. in the U.S. are affected. Those with prescriptions for this medication may be at risk if the capsules were manufactured with quality control deviations.
How to tell if you have this one
Check for NDC code 51672-4001-1 on the packaging. The capsules were manufactured by Taro Pharmaceutical Industries Ltd. in Haifa Bay, Israel and distributed by Taro Pharmaceuticals U.S.A., Inc. in Hawthorne, NY.
- Brand
Taro- Category
Drug
What to do — step by step
Check Product Details
Look for NDC code 51672-4001-1 on the capsule packaging to confirm if it's 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 2.7 years 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.
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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-0246-2021 (January 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0246-2021 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.