Severity
Moderate
ModerateActive
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…
Dr. Reddy's Laboratories, Ltd., of India recalled This recall involves blister packages of prescription medications. The name and strength … - a moderate-severity action.
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 moderate-severity CPSC recall-The products are prescription medications that were labeled and distributed by Dr. Reddy's for institutional ….
- Moderate
- severity level
- 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 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 list the affected scope as About 21,400.
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.
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 - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
About 21,400
Related Recalls
6
0 from same agency
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
| 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 |
| 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. Severity: Moderate. Recall number: 21089.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (21089) against your product. Visit the official CPSC website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: CPSC, reported February 25, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.