CLASS III ONGOING Drug recall · Reported 9 Jul 2025 · FDA Enforcement Report
Pitavastatin Tablets, 2 mg recalled by AvKARE
AvKARE is recalling Pitavastatin Tablets, 2 mg per, distributed nationwide in the US. The recall was initiated on 26 Jun 2025 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-0529-2025
- FDA event ID
- 97160
- Recalling firm
- AvKARE, Pulaski, TN
- Brand
- Pitavastatin
- Manufacturer
- AvKARE
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 26 Jun 2025
- FDA classified
- 16 Jul 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 26 Jun 2025 | Recall initiated by company | |
| 9 Jul 2025 | Published in enforcement report | +13 days |
| 16 Jul 2025 | Classified by FDA | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/Degradation Specifications
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
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurity/Degradation Specifications
Which lots are affected?
Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
Where was it sold?
Nationwide in the USA
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.
Other products in this recall event
1 other product · FDA event 97160This product is part of a recall event; the main page for the event is Pitavastatin Tablets, 1 mg recalled by AvKARE.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Pitavastatin Tablets, 1 mg recalled by AvKAREPitavastatin | AvKARE | Potency & Assay | Nationwide |
More recalls from AvKARE
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
Other Pitavastatin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pitavastatin Tablets, 2 mg recalled by Annora Pharma PrivatePitavastatin Calcium | Annora Pharma Private | Packaging Defects | TN |
| Drug | CLASS III | Pitavastatin Tablets, 2 mg recalled by Orient Pharma Co., Ltd.Pitavastatin | Orient Pharma Co. Ltd. Yunlin Plant | Potency & Assay | NJ |
| Drug | CLASS III | Pitavastatin Tablets, 1 mg recalled by Orient Pharma Co., Ltd.Pitavastatin | Orient Pharma Co. Ltd. Yunlin Plant | Potency & Assay | NJ |
| Drug | CLASS III | Pitavastatin Tablets, 1 mg recalled by AvKAREPitavastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS III | Livalo (pitavatstatin) tablets, 4 mg recalledLivalo | Kowa Pharmaceuticals America | Other | OH, PA, TX |