November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) p
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), an
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., A
Hazard: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
November 26, 2025DrugsFDA
Golden State Medical Supply Inc. recalls NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceu
Hazard: Failed Dissolution Specifications
November 26, 2025DrugsFDA
Imprimis NJOF, LLC recalls Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Us
Hazard: Subpotent Drug
November 26, 2025DrugsFDA
Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceutical
Hazard: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
November 12, 2025DrugsFDA
Aero Healthcare recalls Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB
Hazard: Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
November 12, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottle
Hazard: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
November 12, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottle
Hazard: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
November 12, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottle
Hazard: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
November 12, 2025DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx o
Hazard: Subpotent drug; Clavulanate Potassium component
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
Otsuka ICU Medical LLC recalls 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-798
Hazard: Lack of Assurance of Sterility: Potential for flexible container leaks.
November 5, 2025DrugsFDA
Endo USA, Inc. recalls Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
November 5, 2025DrugsFDA
Endo USA, Inc. recalls Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
November 5, 2025DrugsFDA
Endo USA, Inc. recalls Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
November 5, 2025DrugsFDA
Endo USA, Inc. recalls Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
November 5, 2025DrugsFDA
Letco Medical LLC recalls Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Hazard: Labeling: Not Elsewhere Classified