Lacosamide Tablets, 100mg recall — Annora Pharma Private Ltd (Class II)

Annora Pharma Private Ltd is recorded by the U.S. Food and Drug Administration (FDA) as recalling Lacosamide Tablets, 100mg — a Class II recall, initiated 2026-06-04 and posted to the FDA enforcement report on 2026-07-01, under recall number D-0626-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.”. From the product description, the form is tablets, the strength given is 100mg, the package is described as 60-count bottle and it is marked Rx only. 1 National Drug Code number is printed in the record: 31722-813-60. Distribution is recorded as “Nationwide in the USA” — Nationwide (US), with the recalling firm on record in N/A, India. It is the only recall number the FDA has filed under event ID 99200. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.

Regulatory snapshot

Recall number D-0626-2026
FDA event ID 99200
Classification Class II (intermediate regulatory tier)
Status Ongoing
Recalling firm Annora Pharma Private Ltd
Recall initiated 2026-06-04
Reported by FDA 2026-07-01
Report lag 27 days from initiation to report
Distribution Nationwide in the USA — Nationwide (US)
Firm location on record N/A, India
Product description (source) 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.

Reason reported by FDA

Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.

22 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

6 identifying values matched by exact pattern in the 29-word product description above; each is a literal substring of it.

Product named Lacosamide Tablets
Form Tablets
Strength 100mg
Package 60-count bottle
NDC 31722-813-60
Marketing category Rx only
Manufactured for Camber Pharmaceuticals, Inc.

Other Class II recalls with India on record

27 indexed records carry India as the recalling firm's country, against a dataset that is predominantly United States. These are the ones that also share this recall's FDA tier.

Recall recordRecall numberRecalling firmStrength / formReported
Methohexital Sodium for Injection, 500 mgD-0662-2026Onesource Specialty Pharma Ltd500 mg · for Injection2026-07-15
Pemetrexed for Injection 100mg/VialD-0671-2026Reliance Life Sciences Private Ltd100mg/Vial · for Injection2026-07-15
Pemetrexed for Injection 500mg/VialD-0672-2026Reliance Life Sciences Private Ltd500mg/Vial · for Injection2026-07-15
Bortezomib for Injection 3.5mg/VialD-0673-2026Reliance Life Sciences Private Ltd3.5mg/Vial · for Injection2026-07-15
Azacitidine for Injection 100mg/VialD-0674-2026Reliance Life Sciences Private Ltd100mg/Vial · for Injection2026-07-15
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), 1 KGD-0691-2026Shimoga Chemicals1 KG2026-07-15

Reported in the same month (2026-07)

111 enforcement reports carry a report date in 2026-07; these 8 are the Class II ones nearest this record.

Recall recordRecall numberRecalling firmFDA tierReported
MAJOR, 0.2 mgD-0609-2026The Harvard Drug Group LLCClass II2026-07-01
Fenofibrate Capsules, 200 mgD-0611-2026Ajanta Pharma Usa IncClass II2026-07-01
Corlanor (ivabradine) tablets, 5 mgD-0612-2026Amgen, Inc.Class II2026-07-01
Sensipar (cinacalcet) Tablets, 30mgD-0613-2026Amgen, Inc.Class II2026-07-01
Sensipar (cinacalcet) Tablets, 60mgD-0614-2026Amgen, Inc.Class II2026-07-01
Corlanor (ivabradine) tablets, 7.5mgD-0615-2026Amgen, Inc.Class II2026-07-01
Sensipar (cinacalcet) Tablets, 90mgD-0616-2026Amgen, Inc.Class II2026-07-01
DULOXETINE D/R, 30 mgD-0617-2026Direct RXClass II2026-07-01

Nearest Class II recalls by date

213 of 250 indexed records share the Class II tier; the 2 nearest to 2026-07-01 by report date are listed here.

Recall recordRecall numberRecalling firmStrength / formReported
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, 1295 mLD-0618-2026Central Admixture Pharmacy Services, Inc.1295 mL · Injection2026-07-01
PReye Vitamin See Antioxidant Preservative Free Eye DropsD-0621-2026Preye LLCEye Drops2026-07-01

Reading this record

Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. Match a package against 31722-813-60 at the FDA source to confirm it is covered.

Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Annora Pharma Private Ltd (1 indexed records) aggregates this firm across datasets.

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0626-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.

Source & provenance

Official source
https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0626-2026%22
Source dataset
openFDA Drug Enforcement API
Publication date
2026-07-01
Ingested
2026-08-22
Record hash
da12e01d9ea58577

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.