CLASS II Drug recall · Reported 21 Sep 2022 · FDA Enforcement Report
Lisinopril Blister Card recalled by RemedyRepack
RemedyRepack is recalling Lisinopril Blister Card, distributed in Alaska, Pennsylvania. The recall was initiated on 15 Sep 2022 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-1538-2022
- FDA event ID
- 90873
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Sep 2022
- FDA classified
- 15 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Blood Pressure Medication
Timeline
| 15 Sep 2022 | Recall initiated by company | |
| 15 Sep 2022 | Classified by FDA | +0 days |
| 21 Sep 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00
Where it was distributed
Distributed to two direct accounts in PA and AK.
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Which lots are affected?
Lot # J0636336-073022, J0637605-080422, Exp. date 08/31/2023
Where was it sold?
Distributed to two direct accounts in PA and AK.
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 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 RemedyRepack
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack | RemedyRePack | Manufacturing (CGMP) Deviations | FL, PA, VA |
| Drug | CLASS II | Clindamycin HCl, QTY recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Carvedilol, QTY: per Blister Pack ( blister cards) recalled | RemedyRepack | Nitrosamine Impurity | FL |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled | RemedyRepack | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Potassium Chloride Micro 10mEq recalled by RemedyRepack | RemedyRepack | Potency & Assay | Nationwide |