Food, drugs, devices › Teva Pharmaceuticals USA
Drug recall: Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-05
FDA enforcement event 80790 is a drug recall by Teva Pharmaceuticals USA of North Wales, PA, initiated 6 Aug 2018 and classified Class II, with 7 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 13 Feb 2020. Initiation: voluntary: firm initiated. Teva Pharmaceuticals USA has 98 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Teva Pharmaceuticals USA, North Wales, PA.
Reason for recall
"Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release."
Distribution
"Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 27,816 bottles | Class II | Terminated | 31 Oct 2018 |
| 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 | 3,785 bottles | Class II | Terminated | 31 Oct 2018 |
| 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 | 13,225 bottles | Class II | Terminated | 31 Oct 2018 |
| 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 | 3,397 bottles | Class II | Terminated | 31 Oct 2018 |
| 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 | 82,291 bottles | Class II | Terminated | 31 Oct 2018 |
| 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 | N/A | Class II | Terminated | 31 Oct 2018 |
| 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 | N/A | Class II | Terminated | 31 Oct 2018 |
Context
Other enforcement events for Teva Pharmaceuticals USA
All 98 events for Teva Pharmaceuticals USA
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Feb 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.