CLASS II Drug recall · Reported 8 Aug 2018 · FDA Enforcement Report
Valsartan bottles recalled by Bryant Ranch Prepack
Bryant Ranch Prepack is recalling Valsartan bottles (, distributed in Florida, Hawaii, Indiana. The recall was initiated on 27 Jul 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-1027-2018
- FDA event ID
- 80634
- Recalling firm
- Bryant Ranch Prepack, Burbank, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jul 2018
- FDA classified
- 2 Aug 2018
- Reported
- 8 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 27 Jul 2018 | Recall initiated by company | |
| 2 Aug 2018 | Classified by FDA | +6 days |
| 8 Aug 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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
Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Where it was distributed
Product was distributed in HI, IN, and FL.
Questions about this recall
Why was it recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which lots are affected?
Lot # 111158; Exp. 02/19
Where was it sold?
Product was distributed in HI, IN, and FL.
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.
Other products in this recall event
2 other products · FDA event 80634| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Valsartan bottles recalled by Bryant Ranch PrepackValsartan | Bryant Ranch Prepack | Potency & Assay | FL, HI, IN | |
| CLASS II | Valsartan bottles recalled by Bryant Ranch Prepack | Bryant Ranch Prepack | Potency & Assay | FL, HI, IN |
More recalls from Bryant Ranch Prepack
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 125mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 125mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |