CLASS II Drug recall · Reported 18 Mar 2020 · FDA Enforcement Report
Carbidopa and Levodopa Tablets, USP 25 mg/250mg recalled by Mayne Pharma
Mayne Pharma is recalling Carbidopa and Levodopa Tablets, USP 25 mg/250mg, distributed nationwide in the US. The recall was initiated on 2 Mar 2020 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-0998-2020
- FDA event ID
- 85125
- Recalling firm
- Mayne Pharma, Greenville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Mar 2020
- FDA classified
- 9 Mar 2020
- Reported
- 18 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 2 Mar 2020 | Recall initiated by company | |
| 9 Mar 2020 | Classified by FDA | +7 days |
| 18 Mar 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product Mix-Up: A foreign tablet was found in bottle.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Product Mix-Up: A foreign tablet was found in bottle.
Which lots are affected?
Lot: FG11514 Exp. 05/2021
Where was it sold?
Distributed Nationwide in the USA
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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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 | Duopa (carbidopa and levodopa enteral suspension) recalled by AbbVieDuopa | AbbVie | Potency & Assay | IL, TN |
| Drug | CLASS II | Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg recalledCarbidopa And Levodopa | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |