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Strides Pharma Inc FDA Recalls

11 recalls on file across drugs, 0 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro PharmaceuticaClass IIMar 2, 2026Presence of foreign substance: the firm received complaints
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; DisClass IIJul 9, 2025Failed Dissolution Specifications.
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East BrClass IIMar 5, 2025Presence of foreign substance: Presence of Benzene.
Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East BrunsClass IIMar 5, 2025Presence of foreign substance: Presence of Benzene.
Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 56210Class IIDec 29, 2023Failed Dissolution Specifications
Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life ScieClass IIJun 26, 2023Presence of Foreign Substance: Presence of a small piece of
Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 5621Class IIJul 19, 2022Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle
Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101,Class IIMay 18, 2022CGMP Deviations- AZIDO Impurity levels observed to be above
Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, Class IIMay 18, 2022CGMP Deviations- AZIDO Impurity levels observed to be above
Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, Class IIMay 18, 2022CGMP Deviations- AZIDO Impurity levels observed to be above
Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Class IISep 27, 2021Failed Dissolution Specifications

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