CLASS II Drug recall · Reported 20 Aug 2014 · FDA Enforcement Report
Carbidopa and Levodopa Tablets USP, 25mg/100mg recalled
Teva Pharmaceuticals USA is recalling Carbidopa and Levodopa Tablets USP, 25mg/100mg, distributed nationwide in the US. The recall was initiated on 5 Jun 2014 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-1538-2014
- FDA event ID
- 68522
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2014
- FDA classified
- 13 Aug 2014
- Reported
- 20 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 5 Jun 2014 | Recall initiated by company | |
| 13 Aug 2014 | Classified by FDA | +69 days |
| 20 Aug 2014 | 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 Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
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
Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
Which lots are affected?
lot 29C220, Exp. 11/15
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.
More recalls from Teva Pharmaceuticals USA
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|---|---|---|---|---|---|
| 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 Carbidopa recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg recalledCarbidopa, Levodopa And Entacapone | Rising Pharma Holding | Packaging Defects | Nationwide |
| Drug | CLASS II | Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, Unit Dose recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Carbidopa And Levordopa Tablets, USP 25mg/100mg recalled | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Carbidopa and Levodopa Tablets, USP 25 mg/250mg recalled by Mayne Pharma | Mayne Pharma | Packaging Defects | Nationwide |
| Drug | CLASS II | Duopa (carbidopa and levodopa enteral suspension) recalled by AbbVieDuopa | AbbVie | Potency & Assay | IL, TN |