CLASS III Drug recall · Reported 19 Jul 2017 · FDA Enforcement Report
Paroxetine Extended-Release Tablets USP, 5 mg recalled
Lupin Pharmaceuticals is recalling Paroxetine Extended-Release Tablets USP, 5 mg, distributed nationwide in the US. The recall was initiated on 22 Jun 2017 and the FDA has classified it as Class III.
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-0974-2017
- FDA event ID
- 77606
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Paroxetine
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Jun 2017
- FDA classified
- 12 Jul 2017
- Reported
- 19 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 22 Jun 2017 | Recall initiated by company | |
| 12 Jul 2017 | Classified by FDA | +20 days |
| 19 Jul 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Paroxetine Extended-Release Tablets USP, 5 mg recalled?
Yes. Lupin Pharmaceuticals recalled Paroxetine Extended-Release Tablets USP, 5 mg on 22 Jun 2017. The recall is Class III and its status is Terminated. Recall number D-0974-2017.
Why was it recalled?
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Which lots are affected?
Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019
Where was it sold?
Nationwide in the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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Other Paroxetine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine tablets, USP, 20 mg, Packaged as a) recalledParoxetine | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine tablets, USP, 40 mg, Packaged as a) recalledParoxetine | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine | Apotex | Potency & Assay | Nationwide |