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CPSC recall · Reported February 25, 2021

Dr. Reddy's Recalls Prescription Drug Blister Packages Due to Risk of Poisoning

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…

Recall #
21089
Affected scope
About 21,400
Verify with CPSC →
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Dr. Reddy's Laboratories, Ltd., of India recalled This recall involves blister packages of prescription medications. The name and strength ….

Dr. Reddy's Recalls Prescription Drug Blister Packages Due to Risk of Poisoning was recalled by Dr. Reddy's Laboratories, Ltd., of India in February 25, 2021. Reason: The products are prescription medications that were labeled and distributed by Dr. Reddy's for institutional …. Remedy: Consumers should immediately store the recalled medications in a safe location out of rea…. Verify recall #21089 with the CPSC before acting.

The recall

Dr. Reddy's Laboratories, Ltd., of India issued this CPSC recall-The products are prescription medications that were labeled and distributed by Dr. Reddy's for institutional ….

None
agency class
February 25, 2021
reported

Sourced from official CPSC enforcement records. Verify recall #21089 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution information was not included in the agency filing, so consumers should assume broad potential exposure until the firm publishes point-of-sale details. Consumers holding this product should act on the agency's documented remedy above rather than relying on general guidance.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,472 drugs & medications recalls on record

05001,0001,5002,000 2006201220152018202120242026 448

Product description

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

Reason for recall

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.

Remedy, what to do

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.

Recall Profile

Structured summary of the CPSC recall record
Attribute Value
Agency U.S. Consumer Product Safety Commission
Severity class Not classified by agency
Status Active
Recall number 21089
Date reported February 25, 2021
Date initiated February 25, 2021
Recalling firm Dr. Reddy's Laboratories, Ltd., of India
Affected scope About 21,400
Distribution Not disclosed
Official source CPSC notice →

Profile values are sourced directly from the official CPSC enforcement record. Source: U.S. Consumer Product Safety Commission.

What to do with this recall

Consumers should immediately store the recalled medications in a safe location out of reach of children and contact Dr. Reddy's f…

  • Check the recall number (21089) and product description against the item you own. Search the archive
  • Confirm the current status and remedy on the official CPSC notice before acting. CPSC notice
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official CPSC record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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. Recalled by Dr. Reddy's Laboratories, Ltd., of India. Units affected: About 21,400.
Why was this product recalled?
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.
What should consumers do?
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.
Which agency issued this recall?
This recall was issued by the CPSC on February 25, 2021. CPSC does not publish a hazard classification for this recall. Recall number: 21089.
How do I report an injury from a recalled product?
Report injuries to the issuing agency: CPSC at SaferProducts.gov, NHTSA at nhtsa.gov/report-a-safety-problem, or FDA via MedWatch. Document the product (photos, model/serial numbers, purchase receipts) and seek medical attention. Injury reports help agencies track hazard patterns and may strengthen enforcement actions.

Nationwide recalls with similar severity or category timing

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Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: CPSC, reported February 25, 2021. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026