Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported July 19, 2017
Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this t…
Teva Pharmaceuticals recalled Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: … - a critical-severity action.
Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: … was recalled by Teva Pharmaceuticals in July 19, 2017. Reason: Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testin…. Check the official notice for the remedy. Verify recall #D-0960-2017 with the FDA Drug before acting.
The recall
Teva Pharmaceuticals issued this critical-severity FDA Drug recall-Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testin….
- Critical
- severity level
- Class I
- classification
- July 19, 2017
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0960-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0960-2017) was formally reported on July 19, 2017, with the manufacturer initiating the action on May 31, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Teva Pharmaceuticals is listed as the recalling firm, operating out of Horsham, PA. Federal records list the affected scope as 360 bottles.
The documented reason for this recall is: Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional… Distribution data in the federal record shows the product reached: Nationwide in the US. 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
360 bottles
Related Recalls
6
5 from same agency
Product description
Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19
Reason for recall
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0960-2017 |
| Date reported | July 19, 2017 |
| Date initiated | May 31, 2017 |
| Recalling firm | Teva Pharmaceuticals |
| Firm location | Horsham, PA |
| Affected scope | 360 bottles |
| Distribution | Nationwide in the US |
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-0960-2017) 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? ▼
Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19. Recalled by Teva Pharmaceuticals. Units affected: 360 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 19, 2017. Severity: Critical. Recall number: D-0960-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the US.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0960-2017) 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
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie c…
AbbVie Inc. · 2026-06-03
FDA Food Moderate
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bot…
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 July 19, 2017. 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.