Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported December 17, 2025
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Defective container - seal not adhering to bottles
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Lupin Pharmaceuticals Inc. recalled Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured b… - a moderate-severity action.
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured b… was recalled by Lupin Pharmaceuticals Inc. in December 17, 2025. Reason: Defective container - seal not adhering to bottles. Check the official notice for the remedy. Verify recall #D-0227-2026 with the FDA Drug before acting.
The recall
Lupin Pharmaceuticals Inc. issued this moderate-severity FDA Drug recall-Defective container - seal not adhering to bottles.
- Moderate
- severity level
- Class II
- classification
- December 17, 2025
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0227-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0227-2026) was formally reported on December 17, 2025, with the manufacturer initiating the action on November 5, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Lupin Pharmaceuticals Inc. is listed as the recalling firm, operating out of Naples, FL. Federal records list the affected scope as 52,128 bottles.
The documented reason for this recall is: Defective container - seal not adhering to bottles Distribution data in the federal record shows the product reached: 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 and 1 from Lupin Pharmaceuticals Inc. - 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
52,128 bottles
Related Recalls
6
5 from same agency
Product description
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Reason for recall
Defective container - seal not adhering to bottles
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0227-2026 |
| Date reported | December 17, 2025 |
| Date initiated | November 5, 2025 |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Firm location | Naples, FL |
| Affected scope | 52,128 bottles |
| Distribution | 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-0227-2026) 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? ▼
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 52,128 bottles.
Why was this product recalled? ▼
Defective container - seal not adhering to bottles
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 17, 2025. Severity: Moderate. Recall number: D-0227-2026.
Where was the recalled product distributed? ▼
Distribution: Nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0227-2026) 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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Llorens Pharmaceuticals International Division, Inc. · 2026-05-27
FDA Drug Moderate
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:…
Safecor Health, LLC · 2026-05-27
FDA Drug Moderate
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
IntegraDose Compounding Services LLC · 2026-05-27
FDA Drug Moderate
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, …
Lupin Pharmaceuticals Inc. · 2026-05-27
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 December 17, 2025. 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.