Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported August 7, 2019
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
Failed dissolution specifications : failed results at the 3-month stability time point.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Jubilant Cadista Pharmaceuticals, Inc. recalled Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton con… - a critical-severity action.
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton con… was recalled by Jubilant Cadista Pharmaceuticals, Inc. in August 7, 2019. Reason: Failed dissolution specifications : failed results at the 3-month stability time point.. Check the official notice for the remedy. Verify recall #D-1837-2019 with the FDA Drug before acting.
The recall
Jubilant Cadista Pharmaceuticals, Inc. issued this critical-severity FDA Drug recall-Failed dissolution specifications : failed results at the 3-month stability time point..
- Critical
- severity level
- Class I
- classification
- August 7, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1837-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1837-2019) was formally reported on August 7, 2019, with the manufacturer initiating the action on July 9, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Jubilant Cadista Pharmaceuticals, Inc. is listed as the recalling firm, operating out of Salisbury, MD. Federal records list the affected scope as 11,412 cartons/34,236 blister cards/28 tablets each card.
The documented reason for this recall is: Failed dissolution specifications : failed results at the 3-month stability time point. Distribution data in the federal record shows the product reached: USA 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, 5 from FDA Drug - 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
11,412 cartons/34,236 blister cards/28 tablets each card
Related Recalls
6
5 from same agency
Product description
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
Reason for recall
Failed dissolution specifications : failed results at the 3-month stability time point.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-1837-2019 |
| Date reported | August 7, 2019 |
| Date initiated | July 9, 2019 |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc. |
| Firm location | Salisbury, MD |
| Affected scope | 11,412 cartons/34,236 blister cards/28 tablets each card |
| Distribution | USA 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-1837-2019) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 11,412 cartons/34,236 blister cards/28 tablets each card.
Why was this product recalled? ▼
Failed dissolution specifications : failed results at the 3-month stability time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 7, 2019. Severity: Critical. Recall number: D-1837-2019.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1837-2019) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
FDA Drug Low
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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
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 August 7, 2019. 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.