Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported December 12, 2018
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Aurobindo Pharma USA Inc. recalled Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distri… - a low-severity action.
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distri… was recalled by Aurobindo Pharma USA Inc. in December 12, 2018. Reason: Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot…. Check the official notice for the remedy. Verify recall #D-0289-2019 with the FDA Drug before acting.
The recall
Aurobindo Pharma USA Inc. issued this low-severity FDA Drug recall-Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot….
- Low
- severity level
- Class III
- classification
- December 12, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0289-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0289-2019) was formally reported on December 12, 2018, with the manufacturer initiating the action on November 30, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Aurobindo Pharma USA Inc. is listed as the recalling firm, operating out of East Windsor, NJ. Federal records list the affected scope as 4464 bottles.
The documented reason for this recall is: Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach). Distribution data in the federal record shows the product reached: U.S.A. Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
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.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4464 bottles
Related Recalls
6
0 from same agency
Product description
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30
Reason for recall
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0289-2019 |
| Date reported | December 12, 2018 |
| Date initiated | November 30, 2018 |
| Recalling firm | Aurobindo Pharma USA Inc. |
| Firm location | East Windsor, NJ |
| Affected scope | 4464 bottles |
| Distribution | U.S.A. Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0289-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug 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? ▼
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30. Recalled by Aurobindo Pharma USA Inc.. Units affected: 4464 bottles.
Why was this product recalled? ▼
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 12, 2018. Severity: Low. Recall number: D-0289-2019.
Where was the recalled product distributed? ▼
Distribution: U.S.A. Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0289-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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: FDA Drug, reported December 12, 2018. 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.