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Dr. Reddy's Laboratories, Inc.

Dr. Reddy's Laboratories, Inc. Recalls

All product recalls associated with Dr. Reddy's Laboratories, Inc..

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Recall Summary

Total Recalls

167

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 61–80 of 167 recalls

Ezetimibe Simvastatin 10/10mg (Dr. Reddy's) – Excipient Specifications (2021)

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

Class IIModerate

FDAOct 5, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Ezetimibe Simvastatin 10/20mg (Dr. Reddy's) – Excipient Specifications (2021)

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

Class IIModerate

FDAOct 5, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Ezetimibe Simvastatin 10/80mg (Dr. Reddy's) – Excipient Specifications (2021)

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

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Class IIModerate

FDAOct 5, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Omeprazole Capsules (Dr. Reddy's) – Foreign Object Risk (2021)

CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.

Class IIModerate

FDAOct 5, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Ezetimibe Simvastatin 10/40mg (Dr. Reddy's) – Excipient Specifications (2021)

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

Class IIModerate

FDAOct 5, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Tizanidine HCl Tablets 4mg (Dr. Reddy's) – Tablet Specification Failure (2021)

Failed Tablet/Capsule Specification: Some tablets are shaved

Class IIModerate

FDAJul 19, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Atorvastatin Calcium Tablets (Dr. Reddy's) - Impurity Detection (2021)

Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities

Class IIILow

FDAJun 4, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Atorvastatin Tablets (Dr. Reddy's) – Impurity Specs (2021)

Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities

Class IIILow

FDAMay 4, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Progesterone Capsules (Dr. Reddy's) – dissolution failure (2021)

Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.

Class IIModerate

FDAFeb 26, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Imatinib Mesylate Tablets (Dr. Reddy's) – Poisoning Risk (2021)

This recall involves blister packages of prescription medications. The name and strength of the medication, "For Institutional Use only," "Rx Only," lot number and expiration date are printed on the outside of the package as well as on the individual blister units. The Dr. Reddy's logo and NDC number are printed on the outside of the package. The recalled medications include the following: Recalled Prescription Drugs NDC Numbers Carton Configurations Lot Numbers Expiration Dates Imatinib Mesylate Tablets 100 mg 43598-344-31 3 blister cards of 10 tablets H2000138 2022-0630 Imatinib Mesylate Tablets 400 mg 43598-345-31 3 blister cards of 10 tablets H2000127 2022-0630 Pregabalin Capsules 50 mg 43598-292-66 5 blister cards of 10 capsules T900876 2021-0630 Pregabalin Capsules 75 mg 43598-293-66 5 blister cards of 10 capsules T901021 2021-0731 Pregabalin Capsules 100 mg 43598-294-66 5 blister cards of 10 capsules T901022 2021-0731 Pregabalin Capsules 150 mg 43598-295-66 5 blister cards of 10 capsules T901023 2021-0731 Sevelamer Carbonate Tablets 800 mg 55111-789-11 4 blister cards of 25 tablets T801003, T000009, T900221 2020-1031, 2021-1231, 2021-0228 Tadalafil Tablets 5 mg 43598-575-31 3 blister cards of 10 tablets T000376 2022-0131 Tadalafil Tablets 20 mg 43598-573-31 3 blister cards of 10 tablets T000425 2022-0228

CPSCFeb 25, 2021Nationwide• Dr. Reddy's Laboratories, Ltd., of India