Severity
Moderate
Dr. Reddy's Laboratories, Ltd., of India issued this CPSC recall on February 25, 2021. Classified as Moderate severity. Approximately About 21,400 units are affected. The recall was issued because: The products are prescription medications that were labeled and distributed by Dr. Reddy's for institutional use only. …. This recall notice is sourced from official CPSC enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
This CPSC action (record #21089) was formally reported on February 25, 2021. It is classified under Moderate severity, with a current status of Active. Dr. Reddy's Laboratories, Ltd., of India is listed as the recalling firm. Federal records indicate About 21,400 units are affected.
The documented reason for this recall is: The products are prescription medications that were labeled and distributed by Dr. Reddy's for institutional use only. The prescription medications were distributed by third party wholesalers to retail pharmacies and co… Distribution information was not included in the agency filing, so consumers should assume broad potential exposure until the firm publishes point-of-sale details. The remedy documented by the agency is: Consumers should immediately store the recalled medications in a safe location out of reach of children and contact Dr. Reddy's for a full refund. — consumers holding this product should act on that instruction rather than relying on general guidance.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 1 were also issued by CPSC. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Severity
Moderate
Units Affected
About 21,400
Related Recalls
6
1 from same agency
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
The products are prescription medications that were labeled and distributed by Dr. Reddy's for institutional use only. The prescription medications were distributed by third party wholesalers to retail pharmacies and could have been dispensed to consumers. The packaging of the products is not child resistant and can pose a risk of poisoning if the contents are swallowed by young children.
Consumers should immediately store the recalled medications in a safe location out of reach of children and contact Dr. Reddy's for a full refund.
| Attribute | Value |
|---|---|
| Agency | U.S. Consumer Product Safety Commission |
| Severity class | Moderate |
| Status | Active |
| Recall number | 21089 |
| Date reported | February 25, 2021 |
| Date initiated | February 25, 2021 |
| Recalling firm | Dr. Reddy's Laboratories, Ltd., of India |
| Units affected | About 21,400 |
| Distribution | Not disclosed |
Profile values are sourced directly from the official CPSC enforcement record. Source: U.S. Consumer Product Safety Commission.
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Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).