Sun Pharmaceutical
16 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.
- 2026-06-17FDA-DrugClass IISun Pharmaceutical budesonide recalled for foreign particles
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
- 2026-06-17FDA-DrugClass ISun Pharmaceutical doxorubicin injection recalled for glass particles
Presence of Particulate matter: Particulate matter identified as glass.
- 2026-04-22FDA-DrugClass IIStop using Taro fluocinonide cream
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- 2026-04-22FDA-DrugClass IIStop using Taro Fluocinonide Cream, Lot AD76251
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- 2026-04-22FDA-DrugClass IIStop using Taro fluocinonide cream
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- 2026-02-11FDA-DrugClass IIStop using Sun Pharmaceutical Diclofenac Sodium Gel
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
- 2026-01-21FDA-DrugClass IIIStop using Sun Pharmaceutical clindamycin solution
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
- 2026-01-21FDA-DrugClass IIIStop using recalled fluocinolone acetonide solution
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
- 2025-12-24FDA-DrugClass IIStop using Taro Ciclopirox Shampoo 1%
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
- 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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