Taro Pharmaceuticals U recalls
Taro Pharmaceuticals U appears in 36 official U.S. recall notices indexed by RecallRadar, most recently on 2024-08-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 36 |
|---|---|
| Published | 2012-12-12 to 2024-08-21 |
| By agency | FDA Drug (36) |
| By classification | Class II (22), Class III (11), Class I (3) |
| By status | terminated (35), completed (1) |
| Distribution named in notices | CA, CT, HI, IL, LA, MA, MD, MS, NH, NJ, NY, OH, OK, TX, US, WA |
Recalls
- Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T…
FDA Drug · Class III · 2024-08-21 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing. - Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd
FDA Drug · Class III · 2022-04-06 · Taro Pharmaceuticals U
Reason: Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample - Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dis…
FDA Drug · Class I · 2022-01-19 · Taro Pharmaceuticals U
Reason: Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria - Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd
FDA Drug · Class II · 2021-02-10 · Taro Pharmaceuticals U
Reason: CGMP deviations. - Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. - Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g)…
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. - CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. - Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed by: Valu Merchandisers, CO . 5000 Kansas Ave
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. - TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g)
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. - H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride & Care for H-E-B San Antonio,…
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. - Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceuticals U.S.A. Inc
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. - RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Ca…
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. - Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45…
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. - Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 4…
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. - Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15
FDA Drug · Class III · 2020-08-19 · Taro Pharmaceuticals U
Reason: Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity. - Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd
FDA Drug · Class I · 2020-03-04 · Taro Pharmaceuticals U
Reason: Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions. - Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd
FDA Drug · Class I · 2020-02-19 · Taro Pharmaceuticals U
Reason: Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. - Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro P…
FDA Drug · Class II · 2019-11-06 · Taro Pharmaceuticals U
Reason: Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. - Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Ph…
FDA Drug · Class II · 2019-11-06 · Taro Pharmaceuticals U
Reason: Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. - Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Can…
FDA Drug · Class II · 2019-11-06 · Taro Pharmaceuticals U
Reason: Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. - Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco F…
FDA Drug · Class II · 2019-11-06 · Taro Pharmaceuticals U
Reason: Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. - Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, C…
FDA Drug · Class II · 2019-11-06 · Taro Pharmaceuticals U
Reason: Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. - children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distrib…
FDA Drug · Class II · 2018-11-21 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. - children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, D…
FDA Drug · Class II · 2018-11-21 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. - Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottl…
FDA Drug · Class II · 2018-11-21 · Taro Pharmaceuticals U
Reason: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. - Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by…
FDA Drug · Class III · 2018-02-07 · Taro Pharmaceuticals U
Reason: Failed Content Uniformity Specifications - Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc
FDA Drug · Class III · 2017-11-01 · Taro Pharmaceuticals U
Reason: Cross contamination with other products: traces of Dapsone were found in the finished product. - Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Can…
FDA Drug · Class III · 2017-05-24 · Taro Pharmaceuticals U
Reason: Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate. - Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (N…
FDA Drug · Class II · 2017-04-26 · Taro Pharmaceuticals U
Reason: Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability - Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PR…
FDA Drug · Class III · 2016-11-16 · Taro Pharmaceuticals U
Reason: Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione. - ¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only
FDA Drug · Class III · 2016-06-08 · Taro Pharmaceuticals U
Reason: Subpotent Drug - Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Su…
FDA Drug · Class II · 2015-02-11 · Taro Pharmaceuticals U
Reason: Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup. - Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd
FDA Drug · Class III · 2014-11-05 · Taro Pharmaceuticals U
Reason: Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine AP… - Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only
FDA Drug · Class III · 2014-09-24 · Taro Pharmaceuticals U
Reason: Failed Content Uniformity Specifications. - Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only
FDA Drug · Class III · 2013-12-18 · Taro Pharmaceuticals U
Reason: Subpotent. drug - Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd
FDA Drug · Class II · 2012-12-12 · Taro Pharmaceuticals U
Reason: Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.