Teva Paliperidone 9mg Tablets Recall: Missing Laser Drilling Risk
Teva recalls 9mg Paliperidone Extended Release Tablets due to potential missing laser drilling affecting drug release. Rx only, 30-count and 90-count bottles with specific NDCs and expiration dates.
Lower-risk recall
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Contact the company
What happened, in plain English
Teva is recalling 9mg Paliperidone Extended Release Tablets that may have missing laser drilling, which could affect how the medication releases. This is a drug safety issue requiring attention for those prescribed this medication. Read more at govinfonow.com/recall/39754-teva-paliperidone-9mg-tablets-recall-missing-laser-drilling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39754-teva-paliperidone-9mg-tablets-recall-missing-laser-drilling-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0097-2019
Cite this page
“Teva Paliperidone 9mg Tablets Recall: Missing Laser Drilling Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39754-teva-paliperidone-9mg-tablets-recall-missing-laser-drilling-risk. Based on FDA recall #D-0097-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0097-2019%22&limit=1).
Why it’s dangerous
The tablets may have missing laser drilling, which could cause the medication to not release properly. This might lead to incorrect dosing or reduced effectiveness of the drug.
Who’s affected
People prescribed Paliperidone Extended Release Tablets 9mg by a doctor. Those with the specific bottle sizes and NDC numbers listed are most at risk.
How to tell if you have this one
Check for 30-count bottles (NDC 0591-3695-30) or 90-count bottles (NDC 0591-3695-19) with expiration dates of January 2020 or earlier.
- Brand
Teva Pharmaceuticals USA- Category
Drug
All 7 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0096-2019 | Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Lot #: a) 1220221A, Exp 03/2019; 1269627A, Exp 09/2019; 1274295A, Exp 10/2019; b) 1220222A, Exp 03/2019; 1270501A, Exp 09/2019; 1274296A, Exp 10/2019; 1288766A, Exp 01/2020 | 27,816 bottles |
| D-0097-2019 | Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Lot #: a) 1291192A, Exp 01/2020; b) 1291193A, Exp 01/2020 | 3,785 bottles |
| D-0098-2019 | Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60; Lot #: 1237868A, 1248900A, Exp 5/2020 | 13,225 bottles |
| D-0099-2019 | Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01; Lot #: 1210888A, Exp 03/2019 | 3,397 bottles |
| D-0100-2019 | Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60; Lot #: 1139500A, Exp 04/2019; 1240343A, 1248901M, 1256614M, Exp 05/2020 | 82,291 bottles |
| D-0101-2019 | Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19; Lot #: 1240400A, Exp 05/2019; 1293935M, Exp 12/2019 | N/A |
| D-0102-2019 | PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015; Bulk Lot no 1250668, 15 mg/1000 mg Bulk product No # 1274150, no NDC Codes, bulk exp. date 05/2020 & 10/2020 | N/A |
What to do — step by step
Check Your Medication
Look for the specific bottle sizes and NDC numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0097-2019 (August 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0097-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.