CLASS III Drug recall · Reported 14 Aug 2019 · FDA Enforcement Report
Lovastatin Tablets USP, 40 mg recalled by American Health Packaging
American Health Packaging is recalling Lovastatin Tablets USP, 40 mg, distributed nationwide in the US. The recall was initiated on 19 Feb 2019 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-1584-2019
- FDA event ID
- 83471
- Recalling firm
- American Health Packaging, Columbus, OH
- Brand
- Lovastatin
- Manufacturer
- BluePoint Laboratories
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Feb 2019
- FDA classified
- 2 Aug 2019
- Reported
- 14 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cholesterol Medication
Timeline
| 19 Feb 2019 | Recall initiated by company | |
| 2 Aug 2019 | Classified by FDA | +164 days |
| 14 Aug 2019 | 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
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
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
Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.
Where it was distributed
Nationwide within the USA and Puerto Rico
Questions about this recall
Is Lovastatin Tablets USP, 40 mg recalled?
Yes. American Health Packaging recalled Lovastatin Tablets USP, 40 mg on 19 Feb 2019. The recall is Class III and its status is Terminated. Recall number D-1584-2019.
Why was it recalled?
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Which lots are affected?
Lot #: a) G702705 and b) G702706, Exp. 3/31/2020
Where was it sold?
Nationwide within the USA and Puerto Rico
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 American Health Packaging
All 60| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | American Health Packaging | Potency & Assay | Nationwide |
Other Lovastatin recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lovastatin Tablets USP, 40 mg recalled by Lupin PharmaceuticalsLovastatin | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Lovastatin Tablets USP, 40 mg Unit Dose recalled by AVKARE | AVKARE | Potency & Assay | Nationwide |