CLASS II Drug recall · Reported 27 Nov 2024 · FDA Enforcement Report
Ramipril Capsules USP 5 mg, a) recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Ramipril Capsules USP 5 mg, a) (, distributed nationwide in the US. The recall was initiated on 23 Oct 2024 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-0053-2025
- FDA event ID
- 95610
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Ramipril
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Oct 2024
- FDA classified
- 19 Nov 2024
- Reported
- 27 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Blood Pressure Medication
Timeline
| 23 Oct 2024 | Recall initiated by company | |
| 19 Nov 2024 | Classified by FDA | +27 days |
| 27 Nov 2024 | 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: Active pharmaceutical ingredient was sourced from an unapproved vendor
Product as listed by the FDA
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
Where it was distributed
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Questions about this recall
Is Ramipril Capsules USP 5 mg, a) ( recalled?
Yes. Lupin Pharmaceuticals recalled Ramipril Capsules USP 5 mg, a) ( on 23 Oct 2024. The recall is Class II and its status is Terminated. Recall number D-0053-2025.
Why was it recalled?
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Which lots are affected?
a) NDC 68180-590-09; Lots G326928, exp. date 30-Sep-25, GA00964, exp. date 31-Dec-25, b) NDC 68180-590-01, Lots G326897, G326929, exp. date 30-Sep-25, GA00854, GA00933, GA00954, exp. date 31-Dec-25, c) NDC 68180-590-02, Lot GA00955, exp. date 31-Dec-25
Where was it sold?
Product was distributed to 30 wholesalers/distributors who may have further distributed the product 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 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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Other Ramipril recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ramipril Capsules USP, 10 mg recalled by Hikma Pharmaceuticals USARamipril | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ramipril Capsules USP 5 mg, a) recalled by Lupin PharmaceuticalsRamipril | Lupin Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ramipril Capsules USP 10 mg, a) recalled by Lupin PharmaceuticalsRamipril | Lupin Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Ramipril Capsules, USP, 25 mg recalled by Actavis Laboratories, FL | Actavis Laboratories, FL | Other | Nationwide |