FDA Expands Sun Pharma Carbamazepine Recall Over Black Spots
The recall of Carbamazepine Tablets USP 200 mg has been expanded; no illnesses or injuries have been reported.
5 reports on this incident · first at Sep 1, 2026, 10:06 p.m. ET
Earlier reports
Sep 1, 2026, 10:22 p.m. ET
FDA Reclassifies Sun Pharma Carbamazepine Recall as Class II
The U.S. Food and Drug Administration has reclassified the ongoing recall of Carbamazepine Tablets USP, 200 mg, by Sun Pharmaceutical Industries Inc. as Class II, according to Medical Daily. The agency previously classified the recall differently; the new classification indicates the product may cause temporary or medically reversible health effects, or that the chance of serious harm is remote.
The recall, which remains ongoing, involves 1,968 bottles of the 1,000-count prescription bottles, distributed nationwide. The reason for the recall is black spots on the tablets caused by burnt excipient during manufacturing. No illnesses or injuries have been reported in connection with this recall, Medical Daily reported.
Consumers who have the affected product, identified by NDC 51672-4005-3, are advised to photograph the tablet, keep the bottle and label, and call the dispensing pharmacy to check the manufacturer and lot. They should keep taking the medication while that check happens unless a clinician says otherwise.
Sep 1, 2026, 10:16 p.m. ET
FDA Reports No Illnesses in Ongoing Sun Pharma Carbamazepine Recall
The U.S. Food and Drug Administration has received no reports of illnesses or injuries in connection with the ongoing recall of Carbamazepine Tablets USP, 200 mg, made by Sun Pharmaceutical Industries Inc., according to Medical Daily. The agency has not specified the number or nature of the reports.
The recall, classified as Class II, covers 1,968 bottles in 1,000-count prescription bottles distributed nationwide. The reason for the recall is black spots on the tablets caused by burnt excipient during manufacturing, which may cause temporary or medically reversible health effects, or that the chance of serious harm is remote.
The affected product is identified by NDC 51672-4005-3. Consumers are advised to photograph the tablet, keep the bottle and label, and call the dispensing pharmacy to check the manufacturer and lot. They should keep taking the medication while that check happens unless a clinician says otherwise.
Sep 1, 2026, 10:11 p.m. ET
FDA Closes Sun Pharma Carbamazepine Recall Over Black Spots
The U.S. Food and Drug Administration has closed the recall of Carbamazepine Tablets USP, 200 mg, distributed nationwide by Sun Pharmaceutical Industries Inc., according to Medical Daily. The agency considers the recall carried out.
The recall, classified as Class II, was initiated because black spots on the tablets were caused by burnt excipient during manufacturing. The affected product comes in 1,000-count prescription bottles with NDC 51672-4005-3. No illnesses or injuries have been reported in connection with this recall.
Consumers who still have the product should photograph the tablet, keep the bottle and label, and call the dispensing pharmacy to check the manufacturer and lot. They should keep taking the medication while that check happens unless a clinician says otherwise.
Sep 1, 2026, 10:06 p.m. ETFirst report
Sun Pharma Recalls Carbamazepine Tablets Over Black Spots
Sun Pharmaceutical Industries Inc. is recalling Carbamazepine Tablets USP, 200 mg, in 1,000-count prescription bottles, according to a report from Medical Daily. The recall, classified as Class II by the FDA, affects 1,968 bottles distributed nationwide. The reason for the recall is black spots on the tablets caused by burnt excipient during manufacturing, the report said.
The affected product is identified by NDC 51672-4005-3. The FDA's Class II classification indicates that the product may cause temporary or medically reversible health effects, or that the chance of serious harm is remote. No illnesses or injuries have been reported in connection with this recall, according to Medical Daily.
The recall is ongoing. Consumers who have the affected tablets are advised to photograph the tablet, keep the bottle and label, and call the dispensing pharmacy to check the manufacturer and lot. They should continue taking the medication unless a clinician says otherwise, the report said.
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