Sun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
Sun Pharmaceutical Industries is recalling 1,968 bottles of Carbamazepine 200mg tablets due to CGMP deviations and black spots found on tablets.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without reported hospitalizations or injuries fall into the High severity category (Score 3), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 1,968 bottles of Carbamazepine Tablets, USP, 200mg (NDC 51672-4005-3). The affected product is Lot # AD94033 with an expiration date of 5/31/2028. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the discovery of black spots on tablets resulting from burnt excipient during the manufacturing process.
The affected product was distributed nationwide in the United States. The tablets are prescription-only and are manufactured by Taro Pharmaceutical Industries Ltd. and distributed by Taro Pharmaceuticals USA, Inc.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for a replacement. The recall is classified as FDA Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Medication
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 (2)
- Lot # AD94033
- Exp Date: 5/31/2028.
Distribution
Distributed nationwide across the United States.
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