CLASS III ONGOING Drug recall · Reported 9 Jul 2025 · FDA Enforcement Report
Pitavastatin Tablets, 1 mg recalled by Orient Pharma Co., Ltd.
Orient Pharma Co., Ltd. Yunlin Plant is recalling Pitavastatin Tablets, 1 mg, distributed in New Jersey. The recall was initiated on 11 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-0527-2025
- FDA event ID
- 97076
- Recalling firm
- Orient Pharma Co., Ltd. Yunlin Plant, Yunlin County
- Brand
- Pitavastatin
- Manufacturer
- Teva Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 11 Jun 2025
- FDA classified
- 16 Jul 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 11 Jun 2025 | Recall initiated by company | |
| 9 Jul 2025 | Published in enforcement report | +28 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 Impurities/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, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98.
Where it was distributed
NJ
Questions about this recall
Is Pitavastatin Tablets, 1 mg recalled?
Yes. Orient Pharma Co., Ltd. Yunlin Plant recalled Pitavastatin Tablets, 1 mg on 11 Jun 2025. The recall is Class III and its status is Ongoing. Recall number D-0527-2025.
Why was it recalled?
Failed Impurities/Degradation Specifications.
Which lots are affected?
P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, Exp Date 01/2027.
Where was it sold?
NJ
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 Orient Pharma Co., Ltd. Yunlin Plant
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pitavastatin Tablets, 2 mg recalled by Orient Pharma Co., Ltd.Pitavastatin | Orient Pharma Co., Ltd. Yunlin Plant | Potency & Assay | NJ |
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, 2 mg recalled by AvKAREPitavastatin | AvKARE | Potency & Assay | Nationwide |
| 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 |