The Recall Desk
HighFDA (Drugs)·D-0432-2023·Announced 2023-03-08

Carbidopa and Levodopa Tablets Recalled for Inadequate Blister Packaging Seal

The Harvard Drug Group is recalling Carbidopa and Levodopa Tablets due to inadequate sealing of the blister packaging. The recall affects Lot M04145 distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a packaging defect that compromises product integrity. No reported illnesses or injuries. Classified as a risk-of-harm situation where injury has not yet been reported, per the rubric.

Plain-English summary

The Harvard Drug Group is recalling Carbidopa and Levodopa Tablets, USP 25 mg/100 mg in 10x10 unit dose cartons due to a packaging defect: the blister packaging was not adequately sealed.

The affected lot is M04145 with an expiration date of 01/2024. A total of 17,586 cartons were distributed nationwide in the USA. Consumers who have received this product should contact their pharmacist or healthcare provider for guidance. Do not use the medication if the packaging appears compromised.

The recalled product

Product
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: M
Manufacturer
The Harvard Drug Group
Category
Drug — Prescription Medication
Hazard
Affected units
17,586

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: M04145 Exp. 01/2024

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · The Harvard Drug Group

See all →

Same hazard · seal defect

See all →