CLASS III Drug recall · Reported 19 Jul 2023 · FDA Enforcement Report
Amlodipine Besylate Tablets, USP 10 mg recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Amlodipine Besylate Tablets, USP 10 mg, distributed nationwide in the US. The recall was initiated on 27 Jun 2023 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-0899-2023
- FDA event ID
- 92618
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Amlodipine Besylate
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Jun 2023
- FDA classified
- 7 Jul 2023
- Reported
- 19 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 27 Jun 2023 | Recall initiated by company | |
| 7 Jul 2023 | Classified by FDA | +10 days |
| 19 Jul 2023 | 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
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-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
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
Where it was distributed
Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Questions about this recall
Why was it recalled?
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Which lots are affected?
Lot #: A102887, Exp. 6/2023
Where was it sold?
Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
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.
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Other Amlodipine recalls
All 81| 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 II | Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg recalledAmlodipine Besylate And Benazepril Hydrochloride | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg recalledAmlodipine And Olmesartan Medoxomil | Macleods Pharma Usa | Manufacturing (CGMP) Deviations | Nationwide |