CLASS II ONGOING Drug recall · Reported 14 Jan 2026 · FDA Enforcement Report
Rosuvastatin Tablets, USP, 10 mg recalled by AvKARE
AvKARE is recalling Rosuvastatin Tablets, USP, 10 mg, distributed nationwide in the US. The recall was initiated on 31 Dec 2025 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-0292-2026
- FDA event ID
- 98246
- Recalling firm
- AvKARE, Pulaski, TN
- Brand
- Rosuvastatin
- Manufacturer
- AvPAK
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Dec 2025
- FDA classified
- 20 Jan 2026
- Reported
- 14 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cholesterol Medication
Timeline
| 31 Dec 2025 | Recall initiated by company | |
| 14 Jan 2026 | Published in enforcement report | +14 days |
| 20 Jan 2026 | Classified by FDA | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out of specification for dissolution.
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
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Out of specification for dissolution.
Which lots are affected?
Lot #49124, Exp Date 12/31/2026
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 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 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 | 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 |
| Drug | CLASS III | Pitavastatin Tablets, 2 mg recalled by AvKAREPitavastatin | AvKARE | Potency & Assay | Nationwide |
Other Rosuvastatin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rosuvastatin Tablets 40mg recalled by Glenmark PharmaceuticalsRosuvastatin Calcium | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Rosuvastatin 10mg tablets recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Rosuvastatin 5mg tablets recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) bottle recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Rosuvastatin 5mg tablets recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | Nationwide |