Sun Pharmaceutical
17 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Sun Pharmaceutical and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-01FDA-DrugClass IISun Pharmaceutical Perampanel recalled for tablet strength mix-up
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.
- 2026-06-17FDA-DrugClass IISun Pharmaceutical budesonide recalled for foreign particles
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.
- 2026-06-17FDA-DrugClass ISun Pharmaceutical doxorubicin injection recalled for glass particles
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.
- 2026-04-22FDA-DrugClass IIStop using Taro fluocinonide cream
Taro Pharmaceuticals is recalling one lot of fluocinonide 0.05% cream due to viscosity testing that showed the cream is thicker than the approved specification. This may affect how the medication spreads and absorbs. No injuries have been reported.
- 2026-04-22FDA-DrugClass IIStop using Taro Fluocinonide Cream, Lot AD76251
Taro Pharmaceuticals is recalling Fluocinonide 0.05% Cream (30g tubes, Lot AD76251, expiring 6/30/2026) because the product's thickness is outside the acceptable range. This was discovered during stability testing. The thicker-than-normal cream may affect how well it spreads and works on skin.
- 2026-04-22FDA-DrugClass IIStop using Taro fluocinonide cream
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.
- 2026-02-11FDA-DrugClass IIStop using Sun Pharmaceutical Diclofenac Sodium Gel
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.
- 2026-01-21FDA-DrugClass IIIStop using Sun Pharmaceutical clindamycin solution
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.
- 2026-01-21FDA-DrugClass IIIStop using recalled fluocinolone acetonide solution
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.
- 2025-12-24FDA-DrugClass IIStop using Taro Ciclopirox Shampoo 1%
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.
- 2025-11-05FDA-DrugClass IILisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-052-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- 2025-11-05FDA-DrugClass IILisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-051-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- 2025-11-05FDA-DrugClass IILisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-050-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- 2025-11-05FDA-DrugClass IILisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- 2025-11-05FDA-DrugClass IILisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-048-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- 2025-11-05FDA-DrugClass IILisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-047-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- 2025-11-05FDA-DrugClass IILisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
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