CLASS II Drug recall · Reported 24 Mar 2021 · FDA Enforcement Report
Nortriptyline HCL capsules, 10 mg recalled by Direct Rx
Direct Rx is recalling Nortriptyline HCL capsules, 10 mg, distributed in Georgia. The recall was initiated on 2 Mar 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-0300-2021
- FDA event ID
- 87458
- Recalling firm
- Direct Rx, Dawsonville, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Mar 2021
- FDA classified
- 12 Mar 2021
- Reported
- 24 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 2 Mar 2021 | Recall initiated by company | |
| 12 Mar 2021 | Classified by FDA | +10 days |
| 24 Mar 2021 | Published in enforcement report | +12 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: 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.
Product as listed by the FDA
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
Where it was distributed
GA
Questions about this recall
Is Nortriptyline HCL capsules, 10 mg recalled?
Yes. Direct Rx recalled Nortriptyline HCL capsules, 10 mg on 2 Mar 2021. The recall is Class II and its status is Terminated. Recall number D-0300-2021.
Why was it recalled?
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.
Which lots are affected?
Lot#: 28DE2002 Exp 10/31/22
Where was it sold?
GA
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 21 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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| Drug | CLASS II | Duloxetine D/R, a) 30 mg recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
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| Drug | CLASS II | Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophth Solution recalled by Direct Rx | Direct Rx | Packaging Defects | 5 states |
| Drug | CLASS II | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled | Direct Rx | Potency & Assay | Nationwide |
Other Nortriptyline recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nortriptyline HCl Capsules, USP equivalent to 10mg base recalledNortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A | Manufacturing (CGMP) Deviations | Nationwide |