Sun Pharmaceutical recalls

Sun Pharmaceutical Industries is recalling 17,760 bottles of lisdexamfetamine dimesylate capsules 40 mg, 100-count, because they failed dissolution specifications. The bottles were distributed in Ohio and Mississippi. No injuries have been reported.

Moderate·FDA·Nov 6, 2026

Sun Pharmaceutical is recalling three tretinoin cream USP 0.05% products, sold in 45 g and 20 g tubes under the Taro and Northstar Rx names. The cream failed the FDA's impurity and degradation standards. No injuries have been reported.

Moderate·FDA·Oct 14, 20263 products

Taro Pharmaceuticals is recalling one lot of Lidocaine Ointment USP 5% because testing found the active ingredient strength was outside acceptable limits. The affected lot was identified during long-term stability testing. No injuries have been reported.

Moderate·FDA·Sep 23, 2026

Sun Pharmaceutical is recalling specific lots of Nystatin Cream, USP (15 g tubes) because the medication failed stability testing. This means the cream may not maintain its expected strength or safety over time. The affected lots are AD49605 and AD49606, with expiration dates of 05/31/2027.

Moderate·FDA·Sep 23, 2026

Sun Pharmaceutical's Carbamazepine 200mg tablets (Lot #AD94033, expiring 5/31/2028) contain black spots caused by burnt ingredients during manufacturing. The tablets do not meet quality standards, though no injuries have been reported.

Moderate·FDA·Aug 26, 2026

Sun Pharmaceutical discovered that some bottles labeled as containing 6mg Perampanel tablets actually contained 10mg tablets instead. This mix-up affects one lot (AE01763) distributed nationwide. Patients taking the wrong strength could receive an incorrect dose of this seizure medication.

Moderate·FDA·Jul 1, 2026

Sun Pharmaceutical has recalled budesonide inhalation suspension (1mg/2mL single-dose ampules) due to the presence of black or brown specs and particles found in some vials. The affected lot is BAG0074A with an expiration date of January 31, 2027. This is a quality issue that could affect the safety and sterility of the medication.

Moderate·FDA·Jun 17, 2026

Sun Pharmaceutical's doxorubicin hydrochloride liposome injection vials were found to contain glass particles. The affected vials are lot HAG2581B, which expire in May 2027. About 675 vials were distributed nationwide.

Serious·FDA·Jun 17, 2026

Taro Pharmaceuticals is recalling one lot of fluocinonide 0.05% cream due to a manufacturing defect. Testing found the cream's thickness was thicker than specifications allow, which could affect how the medication works on your skin.

Moderate·FDA·Apr 22, 20263 products

Sun Pharmaceutical is recalling one lot of Diclofenac Sodium Topical Gel, 3% (Lot #AD92721, expiring 3/31/2027) because the gel's thickness is slightly lower than required specifications. The product was distributed nationwide and is sold by prescription only.

Moderate·FDA·Feb 11, 2026

Sun Pharmaceutical has recalled three lots of clindamycin phosphate 1% topical solution due to failed quality tests. The affected batches contain higher-than-acceptable impurities and may not contain the correct amount of active ingredient, which could reduce effectiveness.

Moderate·FDA·Jan 21, 2026

Taro Pharmaceuticals is recalling specific lots of fluocinolone acetonide topical solution (0.01%) because testing found higher-than-allowed levels of an impurity. The affected lots were distributed nationwide. No injuries have been reported.

Moderate·FDA·Jan 21, 2026

Taro Pharmaceuticals is recalling specific lots of Ciclopirox Shampoo 1% because the product failed quality tests for impurities and degradation at the 18-month mark. The affected lots expire January 31, 2026. No injuries have been reported.

Moderate·FDA·Dec 24, 2025