Carbamazepine recalls: 5 FDA reports
Recalls involving Carbamazepine. What was wrong with each batch, and how the FDA graded the risk.
5Reports
0Class I
1Ongoing
2025-10-08Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, Ame
D-0675-2025 · Class II · reported 2025-10-08 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications.
- Product
- Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)
- Where it went
- Nationwide in the USA.
- How much
- 360 cartons
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceutical
D-0365-2022 · Class II · reported 2022-01-19 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.
- Where it went
- Nationwide USA
- How much
- 15,336 Bottles
Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharm
D-0807-2021 · Class II · reported 2021-09-29 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC 0904-6172-61
- Where it went
- NC
- How much
- 4 Cartons of 100 count each
Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceu
D-1317-2020 · Class II · reported 2020-06-10 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05
- Where it went
- USA Nationwide and Puerto Rico
- How much
- 6228 Bottles
Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Indu
D-0049-2015 · Class III · reported 2014-11-05 · Terminated
- Why it was recalled
- 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.
- Product
- Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3.
- Where it went
- IL, OH, LA
- How much
- 1,966 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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