CLASS II Drug recall · Reported 4 Sep 2013 · FDA Enforcement Report
Propranolol Hydrochloride Tablets, USP, 10 mg recalled
Teva Pharmaceuticals USA is recalling Propranolol Hydrochloride Tablets, USP, 10 mg, distributed nationwide in the US. The recall was initiated on 6 Aug 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-924-2013
- FDA event ID
- 65912
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2013
- FDA classified
- 27 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 6 Aug 2013 | Recall initiated by company | |
| 27 Aug 2013 | Classified by FDA | +21 days |
| 4 Sep 2013 | 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 Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.
Product as listed by the FDA
Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.
Which lots are affected?
Lot #: 6A301029, Exp 1/2016; 6A303025, Exp. 3/2016
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.
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|---|---|---|---|---|---|
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| 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 Propranolol recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Propranolol Hydrochloride Tablets, 20 mg recalled by Cardinal HealthcarePropranolol Hydrochloride | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Propranolol HCl recalled by Gyma Laboratories Of Amer | Gyma Laboratories Of Amer | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Propranolol Hydrochloride Injection, USP 1 mg/mL Single Dose Vial recalledPropranolol | Fresenius Kabi USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Propranolol HCL ER, Capsule, 60 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Propranolol HCL, Tablet, 10 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |