CLASS III Drug recall · Reported 28 Sep 2016 · FDA Enforcement Report
Escitalopram Tablets USP 20 mg recalled by Lupin
Lupin is recalling Escitalopram Tablets USP 20 mg, distributed nationwide in the US. The recall was initiated on 24 Mar 2016 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-1516-201
- FDA event ID
- 74944
- Recalling firm
- Lupin, Verna, Salcette, Goa
- Brand
- Escitalopram
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Mar 2016
- FDA classified
- 21 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 24 Mar 2016 | Recall initiated by company | |
| 21 Sep 2016 | Classified by FDA | +181 days |
| 28 Sep 2016 | 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
Labeling: Incorrect or Missing Lot and/or Expiration Date
Product as listed by the FDA
Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Expiration Date
Which lots are affected?
Lot # G510086; Exp. 11/17
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 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 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.
More recalls from Lupin
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pravastatin Sodium USP, tablets, 40 mg recalled by LupinPravastatin Sodium | Lupin | Other | Nationwide |
| Drug | CLASS III | Amlodipine Besylate Tablets USP, 10mg recalled by LupinAmlodipine Besylate | Lupin | Manufacturing (CGMP) Deviations | |
| Drug | CLASS III | Amlodipine Besylate Tablets USP, 2.5mg recalled by LupinAmlodipine Besylate | Lupin | Manufacturing (CGMP) Deviations |