CLASS II Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, Unit Dose recalled
The Harvard Drug Group is recalling Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, Unit Dose, distributed nationwide in the US. The recall was initiated on 23 Feb 2023 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-0432-2023
- FDA event ID
- 91751
- Recalling firm
- The Harvard Drug Group, La Vergne, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2023
- FDA classified
- 2 Mar 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
Timeline
| 23 Feb 2023 | Recall initiated by company | |
| 2 Mar 2023 | Classified by FDA | +7 days |
| 8 Mar 2023 | 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
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
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/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Which lots are affected?
Lot: M04145 Exp. 01/2024
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.
More recalls from The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
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 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 |
| Drug | CLASS II | Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg recalledCarbidopa And Levodopa | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |