CLASS III Drug recall · Reported 14 Sep 2016 · FDA Enforcement Report
Amlodipine Besylate Tablets USP, 5mg recalled by Lupin
Lupin is recalling Amlodipine Besylate Tablets USP, 5mg. The recall was initiated on 19 Feb 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-1492-2016
- FDA event ID
- 74964
- Recalling firm
- Lupin, Verna, Salcette, Goa
- Brand
- Amlodipine Besylate
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Feb 2016
- FDA classified
- 6 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Blood Pressure Medication
Timeline
| 19 Feb 2016 | Recall initiated by company | |
| 6 Sep 2016 | Classified by FDA | +200 days |
| 14 Sep 2016 | Published in enforcement report | +8 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: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Product as listed by the FDA
Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09
Where it was distributed
US No recalled product was distributed to any foreign consignees by Lupin.
Questions about this recall
Is Amlodipine Besylate Tablets USP, 5mg recalled?
Yes. Lupin recalled Amlodipine Besylate Tablets USP, 5mg on 19 Feb 2016. The recall is Class III and its status is Terminated. Recall number D-1492-2016.
Why was it recalled?
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Which lots are affected?
Lot #: G304799, Exp. 4/2016
Where was it sold?
US No recalled product was distributed to any foreign consignees by Lupin.
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.
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 | Escitalopram Tablets USP 20 mg recalled by LupinEscitalopram | Lupin | Other | Nationwide |
| Drug | CLASS III | Amlodipine Besylate Tablets USP, 10mg recalled by LupinAmlodipine Besylate | Lupin | Manufacturing (CGMP) Deviations |
Other Amlodipine recalls
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Amlodipine Besylate Tablets, USP 10 mg recalled by Lupin PharmaceuticalsAmlodipine Besylate | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg recalledAmlodipine And Olmesartan Medoxomil | Macleods Pharma Usa | Manufacturing (CGMP) Deviations | Nationwide |