CLASS II Drug recall · Reported 10 Feb 2021 · FDA Enforcement Report
Nortriptyline HCl Capsules, USP equivalent to 10mg base recalled
Taro Pharmaceuticals U is recalling Nortriptyline HCl Capsules, USP equivalent to 10mg base, distributed nationwide in the US. The recall was initiated on 8 Jan 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0246-2021
- FDA event ID
- 87152
- Recalling firm
- Taro Pharmaceuticals U, Hawthorne, NY
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jan 2021
- FDA classified
- 1 Feb 2021
- Reported
- 10 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 8 Jan 2021 | Recall initiated by company | |
| 1 Feb 2021 | Classified by FDA | +24 days |
| 10 Feb 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations.
Product as listed by the FDA
Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP deviations.
Which lots are affected?
AC05096, AC05098, and AC05099; Exp 10/31/2022
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Nortriptyline recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nortriptyline HCL capsules, 10 mg recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | GA |
| Drug | CLASS II | Nortriptyline 10 mg/ Susp, Health Innov Pharmacy recalled | Health Innovations Pharmacy | Sterility | NC |
| Drug | CLASS II | Nortriptyline HCL, Capsule, 75 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Nortriptyline HCL, Capsule, 50 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Nortriptyline HCL, Capsule, 10 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |