CLASS III ONGOING Drug recall · Reported 25 Mar 2026 · FDA Enforcement Report
Pitavastatin Tablets, 2 mg recalled by Annora Pharma Private
Annora Pharma Private is recalling Pitavastatin Tablets, 2 mg, distributed in Tennessee. The recall was initiated on 3 Feb 2026 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-0391-2026
- FDA event ID
- 98543
- Recalling firm
- Annora Pharma Private, Hyderabad, N/A
- Brand
- Pitavastatin Calcium
- Manufacturer
- NorthStar RxLLC
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 3 Feb 2026
- FDA classified
- 16 Mar 2026
- Reported
- 25 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 3 Feb 2026 | Recall initiated by company | |
| 16 Mar 2026 | Classified by FDA | +41 days |
| 25 Mar 2026 | Published in enforcement report | +9 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 tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.
Where it was distributed
TN
Questions about this recall
Why was it recalled?
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Which lots are affected?
Lot #: A252487, Exp 05/31/2027
Where was it sold?
TN
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.
More recalls from Annora Pharma Private
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lacosamide Tablets, USP, C V, 100mg recalled by Annora Pharma PrivateLacosamide | Annora Pharma Private | Packaging Defects | Nationwide |
Other Pitavastatin recalls
All 7| 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 |
| Drug | CLASS III | Pitavastatin Tablets, 2 mg recalled by AvKAREPitavastatin | AvKARE | Potency & Assay | Nationwide |
| 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 |