East Brunswick, NJ, United States
Strides Pharma Inc. recalls
9 recalls recorded since 2018, most recently on 2 March 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)3
Terminated or completed6
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 2 March 2026
- Reason
- Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0390-2026
- Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
Ongoing Class II Drugs
- Recall started
- 9 July 2025
- Reason
- Failed Dissolution Specifications.
- Distribution
- Product was distributed nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0546-2025
- Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
Ongoing Class II Drugs
- Recall started
- 5 March 2025
- Reason
- Presence of foreign substance: Presence of Benzene.
- Distribution
- Nationwide in the U.S
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0294-2025, D-0293-2025
- Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02
- Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02
Terminated Class II Drugs
- Recall started
- 29 December 2023
- Terminated
- 1 July 2025
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0260-2024
- Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16
Terminated Class II Drugs
- Recall started
- 26 June 2023
- Terminated
- 15 May 2024
- Reason
- Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0895-2023
- Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipur
Terminated Class II Drugs
- Recall started
- 19 July 2022
- Terminated
- 21 June 2023
- Reason
- Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1330-2022
- Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.
Terminated Class II Drugs
- Recall started
- 18 May 2022
- Terminated
- 20 October 2023
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0973-2022, D-0974-2022, D-0972-2022
- Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Dist
- Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Dis
- Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Dist
Terminated Class II Drugs
- Recall started
- 27 September 2021
- Terminated
- 26 October 2022
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0006-2022
- Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, ND
Terminated Class III Drugs
- Recall started
- 22 December 2020
- Terminated
- 26 January 2022
- Reason
- Failed Moisture Limits
- Distribution
- PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0180-2021
- NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.