CLASS II Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
Hydralazine HCL Tablets, USP, 50 mg in a single blister package recalled
Teva Pharmaceuticals USA is recalling Hydralazine HCL Tablets, USP, 50 mg in a single blister package, distributed nationwide in the US. The recall was initiated on 18 Dec 2013 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-1075-2014
- FDA event ID
- 67141
- Recalling firm
- Teva Pharmaceuticals USA, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2013
- FDA classified
- 4 Feb 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 18 Dec 2013 | Recall initiated by company | |
| 4 Feb 2014 | Classified by FDA | +48 days |
| 12 Feb 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
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
Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (single blister).
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Which lots are affected?
Lot # 6A201018VA; Exp. 01/14.
Where was it sold?
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.
Other products in this recall event
1 other product · FDA event 67141This product is part of a recall event; the main page for the event is Hydralazine HCL Tablets, USP, 25 mg in a single blister package recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hydralazine HCL Tablets, USP, 25 mg in a single blister package recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
More recalls from Teva Pharmaceuticals USA
All 280| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Hydralazine recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HydrALAZINE Hydrochloride recalled by Sky Packaging | SKY Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | HydrALAZINE Hydrochloride , USP, 50mg recalled by Sky Packaging | SKY Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Hydralazine HCl Tablets, USP, 25mg recalled by The Harvard Drug Group | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | HydrALAZINE Hydrochloride Tablets, USP 10mg recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS III | HydrALAZINE Hydrochloride Tablets, USP, 10 mg (10 x per unit dose recalled | Amerisource Health Services | Potency & Assay | Nationwide |