FDA Recall Database: Class II Recall: LACOSAMIDE by Annora Pharma Private Limited

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Annora Pharma Private Limited and the affected product is described in FDA's record as: Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.. FDA's stated reason for the recall is: Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.. The recall is tracked under FDA recall number D-0626-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60. -- and the recall number D-0626-2026. If it matches, stop using or distributing it and contact Annora Pharma Private Limited or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Annora Pharma Private Limited’s FDA history

Argus HQ has recorded 1 total FDA action tied to Annora Pharma Private Limited: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.) and recall number D-0626-2026, then follow Annora Pharma Private Limited's recall instructions.

Has Annora Pharma Private Limited had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Annora Pharma Private Limited so far. Argus ingests new FDA enforcement records daily.

What is the FDA recall number for this event?

FDA recall number D-0626-2026.

Related enforcement actions