thejoe Teva Pharmaceuticals USA

Teva Pharmaceuticals USA: 196 FDA recall reports

Every drug recall the FDA has published for Teva Pharmaceuticals USA. The fault, and how the agency graded it.

196Reports

4Class I

22Ongoing

2022-02-09Most recent

4 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	155
Class III	37
Class I	4

By year reported

Year	Reports
2013	1
2014	32
2015	7
2016	12
2017	18
2018	38
2019	6
2020	22
2021	53
2022	7

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx On

D-0522-2022 · Class III · reported 2022-02-09 · Terminated

Why it was recalled: Mislabeling
Product: Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42
Where it went: USA Nationwide
How much: 6430 cartons

Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx o

D-0521-2022 · Class III · reported 2022-02-09 · Terminated

Why it was recalled: Mislabeling
Product: Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28
Where it went: USA Nationwide
How much: 218174 cartons

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx On

D-0461-2022 · Class II · reported 2022-02-09 · Terminated

Why it was recalled: Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Product: Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01
Where it went: Nationwide in the USA
How much: 6205 100-count bottles

Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, N

D-0520-2022 · Class II · reported 2022-02-09 · Terminated

Why it was recalled: Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Product: Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
Where it went: nationwide in the USA
How much: 1,175 Bottles

Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15

D-0373-2022 · Class II · reported 2022-01-26 · Terminated

Why it was recalled: Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Product: Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ
Where it went: Nationwide in the USA
How much: a) 66,099 dropper bottles; b) 21,243 dropper bottles

MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only,

D-0370-2022 · Class II · reported 2022-01-19 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.
Where it went: Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
How much: 7,400 cartons

Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx O

D-0371-2022 · Class II · reported 2022-01-19 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.
Where it went: Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
How much: 11,450 vials

Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b)

D-0294-2022 · Class II · reported 2021-12-29 · Terminated

Why it was recalled: Subpotent
Product: Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454
Where it went: nationwide
How much: a) 86,790 and b) 25,416 bottles

Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (

D-0232-2022 · Class II · reported 2021-11-24 · Terminated

Why it was recalled: Labelling: Incorrect Exp. Date
Product: Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laboratories FL. Inc, Fort Lauderdale FL. 33314 USA, Distributed by Avista Pharma Inc. Parsippany, NJ 07054 USA. NDC 62037-597-90
Where it went: Distributed Nationwide in the USA
How much: 32316 bottles

Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laborato

D-0235-2022 · Class III · reported 2021-11-24 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications
Product: Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04
Where it went: Nationwide and Puerto Rico
How much: 64,978 patches

AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd

D-0023-2022 · Class II · reported 2021-10-27 · Terminated

Why it was recalled: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Product: AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
Where it went: USA Nationwide
How much: 1,978 inhalers

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not F

D-0022-2022 · Class II · reported 2021-10-27 · Terminated

Why it was recalled: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Product: AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.
Where it went: USA Nationwide
How much: 3,240 inhalers

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mkt

D-0024-2022 · Class II · reported 2021-10-27 · Terminated

Why it was recalled: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Product: AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.
Where it went: USA Nationwide
How much: 4,850 inhalers

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mkt

D-0025-2022 · Class II · reported 2021-10-27 · Terminated

Why it was recalled: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Product: AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06
Where it went: USA Nationwide
How much: 5,500 inhalers

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not F

D-0021-2022 · Class II · reported 2021-10-27 · Terminated

Why it was recalled: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Product: AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08
Where it went: USA Nationwide
How much: 10,665 inhalers

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis

D-0775-2021 · Class II · reported 2021-09-08 · Terminated

Why it was recalled: CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Product: Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
Where it went: Product was distributed nationwide.
How much: 4,587 bottles

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis

D-0776-2021 · Class II · reported 2021-09-08 · Terminated

Why it was recalled: CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Product: Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01
Where it went: Product was distributed nationwide.
How much: 4,992 bottles

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis

D-0774-2021 · Class II · reported 2021-09-08 · Terminated

Why it was recalled: CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Product: Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01
Where it went: Product was distributed nationwide.
How much: 9,655 bottles

Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wal

D-0738-2021 · Class II · reported 2021-08-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
Where it went: Product was distributed Nationwide, including Puerto Rico.
How much: 12,698 vials

DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parentera

D-0730-2021 · Class II · reported 2021-08-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13
Where it went: Product was distributed Nationwide, including Puerto Rico.
How much: 1,351 vials

Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicine

D-0737-2021 · Class II · reported 2021-08-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
Where it went: Product was distributed Nationwide, including Puerto Rico.
How much: 434,229 vials

Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-00

D-0731-2021 · Class II · reported 2021-08-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Where it went: Product was distributed Nationwide, including Puerto Rico.
How much: 193,845 vials

Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0

D-0739-2021 · Class II · reported 2021-08-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01
Where it went: Product was distributed Nationwide, including Puerto Rico.
How much: 34,100 vials

Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North

D-0736-2021 · Class II · reported 2021-08-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
Where it went: Product was distributed Nationwide, including Puerto Rico.
How much: 16,644 vials

Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-00

D-0743-2021 · Class II · reported 2021-08-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Where it went: Product was distributed Nationwide, including Puerto Rico.
How much: 50,713 vials

Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc

D-0734-2021 · Class II · reported 2021-08-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11
Where it went: Product was distributed Nationwide, including Puerto Rico.
How much: 2,091 vials

Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Ph

D-0747-2021 · Class II · reported 2021-08-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91
Where it went: Product was distributed Nationwide, including Puerto Rico.
How much: 42,046 vials

Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North

D-0744-2021 · Class II · reported 2021-08-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01
Where it went: Product was distributed Nationwide, including Puerto Rico.
How much: 3,067 vials

Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North W

D-0745-2021 · Class II · reported 2021-08-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01
Where it went: Product was distributed Nationwide, including Puerto Rico.
How much: 6,184 vials

Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL m

D-0732-2021 · Class II · reported 2021-08-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
Where it went: Product was distributed Nationwide, including Puerto Rico.
How much: 16,226 vials

Showing the 30 most recent of 196. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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