Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Jun 17, 2026 (4 months ago)

Perampanel CIII Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

Cause type: Labeling / mix-up

Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.

What was recalled

Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6

Affected NDC 51672-4206-06

Compare with the code on your package — it is the most precise check available.

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Perampanel
NDC 51672-4206
6 mg/1 Tablet, Film Coated
Oral
Sun Pharmaceutical Industries, Inc. Rx · CIII
Recalling firm
Sun Pharmaceutical Industries INC
NDC code
51672-4206-6
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0628-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other recalls by Sun Pharmaceutical Industries INC

All 2026 recalls
Class II · Moderate risk

Carbamazepine Tablets

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Ongoing cGMP deviation Sun Pharmaceutical Industries INC NDC 51672-4005-3 D-0770-2026
Class II · Moderate risk

Budesonide Inhalation Suspension

Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution

Ongoing Particulate / foreign matter Sun Pharmaceutical Industries INC NDC 47335-633-49 D-0607-2026

Other labeling / mix-up recalls from 2026

All labeling / mix-up recalls
Unclassified

0.9% Sodium Chloride Injection

Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj.10 mEq

Ongoing Labeling / mix-up Otsuka ICU Medical LLC NDC 0990-7984-23 Recall number pending
Class II · Moderate risk

fentaNYL Citrate

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).

Ongoing Labeling / mix-up OurPharma LLC NDC 73013-1013-01 D-0864-2026
Class I · High risk

Morphine Sulfate Injection

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Ongoing Labeling / mix-up Fresenius Kabi USA, LLC D-0788-2026