Class II · Moderate risk
Carbamazepine Tablets
CGMP deviations: tablets with black specks.
Is Carbamazepine recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Carbamazepine (14 total). Check the affected lots below.
Most common reason: Dissolution failure (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Carbamazepine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Carbamazepine recalls in 2026
2 initiated in 2026, 14 in total — newest first
Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Carbamazepine Extended-Release Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Carbamazepine Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Carbamazepine 200mg Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Carbamazepine 200 mg Tablets
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Class II · Moderate risk
Carbamazepine Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Carbamazepine
Failed Dissolution Specifications
Class III · Low risk
Carbamazepine Oral Suspension USP
Subpotent Drug: low out of specification results.
Class II · Moderate risk
Carbamazepine Oral Suspension
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Class III · Low risk
Carbamazepine Tablets USP
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
Class II · Moderate risk
carBAMazepine ER
Labeling: Label Mixup: carBAMazepine ER, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: ISOSORBIDE DINITRATE ER, Tablet, 40 mg, NDC 57664060088, Pedigree: AD23082_4, EXP: 5/3/2014; SIROLIMUS, Tablet, 1 mg, NDC 00008104105, Pedigree: W003329, EXP: 6/18/2014.
Class II · Moderate risk
carBAMazepine ER
Labeling:Label Mixup; carBAMazepine ER, Capsule, 200 mg may be potentially mislabeled as ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: AD46333_1, EXP: 5/15/2014.
Class II · Moderate risk
carBAMazepine ER Tablet
Labeling: Label Mixup; carBAMazepine ER Tablet, 200 mg may be potentially mislabeled as ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: AD60272_1, EXP: 5/22/2014.
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