CLASS II ONGOING Drug recall · Reported 18 Jun 2025 · FDA Enforcement Report
Chlorthalidone Tablets, USP, 25 mg Unit Dose cards recalled by AvKARE
AvKARE is recalling Chlorthalidone Tablets, USP, 25 mg Unit Dose cards per, distributed nationwide in the US. The recall was initiated on 9 May 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-0461-2025
- FDA event ID
- 96866
- Recalling firm
- AvKARE, Pulaski, TN
- Brand
- Chlorthalidone
- Manufacturer
- AvPAK
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 May 2025
- FDA classified
- 9 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 9 May 2025 | Recall initiated by company | |
| 9 Jun 2025 | Classified by FDA | +31 days |
| 18 Jun 2025 | 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
Failed Dissolution 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
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot # 47947, Exp 05/31/2026
Where was it sold?
Nationwide 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 | 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 Chlorthalidone recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Chlorthalidone Tablets, USP, 25 mg recalled by Inventia HealthcareChlorthalidone | Inventia Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr recalledChlorthalidone | Inventia Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Chlorthalidone Tablets, USP, 25MG recalled by Cardinal HealthcareChlorthalidone | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Chlorthalidone Tablets USP 25 mg recalledChlorthalidone | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Chlorthalidone, Tablet, 50 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |