CLASS II Drug recall · Reported 23 Jan 2019 · FDA Enforcement Report
Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg recalled
Teva Pharmaceuticals USA is recalling Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, distributed nationwide in the US. The recall was initiated on 19 Dec 2018 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-0381-2019
- FDA event ID
- 81840
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Dec 2018
- FDA classified
- 16 Jan 2019
- Reported
- 23 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 19 Dec 2018 | Recall initiated by company | |
| 16 Jan 2019 | Classified by FDA | +28 days |
| 23 Jan 2019 | Published in enforcement report | +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 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
Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA 19454
Where it was distributed
U.S.A. nationwide
Questions about this recall
Why was it recalled?
Failed dissolution specifications
Which lots are affected?
Lot #: a) 49O005, 49O006, 49O007, 49O010, Exp 02/2019; b) 49O005, 49O009, 49O010, Exp 02/2019
Where was it sold?
U.S.A. nationwide
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 Teva Pharmaceuticals USA
All 281| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets recalledMetoclopramide | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Olmesartan Medoxomil recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Olmesartan Medoxomil Tablets, USP, 20 mg recalled by Ascend LaboratoriesOlmesartan Medoxomil | Ascend Laboratories | Other | Nationwide |
| Drug | CLASS II | Olmesartan Medoxomil Tablets 20 mg recalled by Ascend LaboratoriesOlmesartan Medoxomil | Ascend Laboratories | Manufacturing (CGMP) Deviations | Nationwide |