Apotex Inc.: 42 FDA recall reports
Every drug recall the FDA has published for Apotex Inc.. The fault, and how the agency graded it.
42Reports
2Class I
0Ongoing
2020-06-24Most recent
2 Class I on this pageClass 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 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
By year reported
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.
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apot
D-1303-2020 · Class II · reported 2020-06-24 · Completed
- Why it was recalled
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1
- Where it went
- Nationwide.
- How much
- 305,963 bottles
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores
D-0316-2020 · Class II · reported 2019-11-20 · Completed
- Why it was recalled
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Product
- Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00
- Where it went
- Nationwide
- How much
- 1,132,453 bottles
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets ND
D-0318-2020 · Class II · reported 2019-11-20 · Completed
- Why it was recalled
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Product
- Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716
- Where it went
- Nationwide
- How much
- 162,344 bottles
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free
D-0317-2020 · Class II · reported 2019-11-20 · Completed
- Why it was recalled
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Product
- Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011
- Where it went
- Nationwide
- How much
- 31,968 bottles
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hun
D-0319-2020 · Class II · reported 2019-11-20 · Completed
- Why it was recalled
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Product
- Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8
- Where it went
- Nationwide
- How much
- 215,387 bottles
Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 D
D-0315-2020 · Class II · reported 2019-11-20 · Completed
- Why it was recalled
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Product
- Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015
- Where it went
- Nationwide
- How much
- 42,873 bottles
Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co
D-0314-2020 · Class II · reported 2019-11-20 · Completed
- Why it was recalled
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Product
- Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06
- Where it went
- Nationwide
- How much
- 259,647 bottles
Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto,
D-0153-2020 · Class III · reported 2019-11-06 · Terminated
- Why it was recalled
- Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
- Product
- Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8
- Where it went
- IL, MS, NJ, OH, TX
- How much
- 1968 bottles
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) p
D-0992-2019 · Class II · reported 2019-03-13 · Completed
- Why it was recalled
- Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
- Product
- Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb.
- Where it went
- Nationwide in the USA.
- How much
- 82,705 cartons
Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g
D-0841-2018 · Class II · reported 2018-06-13 · Terminated
- Why it was recalled
- Presence of foreign substance: glass particles
- Product
- Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1
- Where it went
- Nationwide
- How much
- Unknown
Class I
Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, M
D-0840-2018 · Class I · reported 2018-05-23 · Terminated
- Why it was recalled
- Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
- Product
- Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
- Where it went
- Nationwide in the USA.
- How much
- 13453 vials
Class I
Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only,
D-0839-2018 · Class I · reported 2018-05-23 · Terminated
- Why it was recalled
- Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
- Product
- Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4
- Where it went
- Nationwide in the USA.
- How much
- 121693 vials
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario,
D-0475-2017 · Class II · reported 2017-03-01 · Terminated
- Why it was recalled
- Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
- Product
- CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0
- Where it went
- Distributed Nationwide
- How much
- 19,584 bottles
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada,
D-0471-2017 · Class III · reported 2017-02-15 · Terminated
- Why it was recalled
- Superpotent Drug: Product may not meet specifications throughout shelf life.
- Product
- Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
- Where it went
- Nationwide in the USA
- How much
- 67,946 bottles
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 6
D-0009-2016 · Class II · reported 2015-10-21 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility: Failed preservative effectiveness testing
- Product
- Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
- Where it went
- Nationwide
- How much
- 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufa
D1834-2015 · Class III · reported 2015-10-07 · Terminated
- Why it was recalled
- Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
- Product
- Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5.
- Where it went
- Nationwide and Puerto Rico
- How much
- 2,075 bottles
Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured
D-1814-2015 · Class II · reported 2015-09-23 · Terminated
- Why it was recalled
- Failed Stability Specifications: product may not meet specification limit for assay test.
- Product
- Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5
- Where it went
- Nationwide and Puerto Rico
- How much
- 117,644 Bottles
Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for A
D-1215-2015 · Class II · reported 2015-07-15 · Terminated
- Why it was recalled
- Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
- Product
- Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India, NDC 60505-0209-1
- Where it went
- Nationwide, Hawaii and Puerto Rico
- How much
- 4,584 bottles
Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive
D-1212-2015 · Class II · reported 2015-07-15 · Terminated
- Why it was recalled
- Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
- Product
- Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9
- Where it went
- Nationwide, Hawaii and Puerto Rico
- How much
- 45,708 bottles
Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive
D-1213-2015 · Class II · reported 2015-07-15 · Terminated
- Why it was recalled
- Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
- Product
- Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3162-9
- Where it went
- Nationwide, Hawaii and Puerto Rico
- How much
- 23,178 bottles
Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive,
D-1214-2015 · Class II · reported 2015-07-15 · Terminated
- Why it was recalled
- Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
- Product
- Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9
- Where it went
- Nationwide, Hawaii and Puerto Rico
- How much
- 23,076 bottles
Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toront
D-1081-2015 · Class III · reported 2015-05-20 · Terminated
- Why it was recalled
- Subpotent drug
- Product
- Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
- Where it went
- Nationwide
- How much
- 5,352 bottles
Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister
D-1080-2015 · Class III · reported 2015-05-20 · Terminated
- Why it was recalled
- Subpotent drug
- Product
- Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
- Where it went
- Nationwide
- How much
- 6,467 bottles/ blister cartons
Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister
D-1079-2015 · Class III · reported 2015-05-20 · Terminated
- Why it was recalled
- Subpotent drug
- Product
- Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
- Where it went
- Nationwide
- How much
- 23,274 bottles/ blister cartons
Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 m
D-0487-2015 · Class III · reported 2015-04-22 · Terminated
- Why it was recalled
- CGMP Deviations: Product excipient was not re-tested at the appropriate date.
- Product
- Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
- Where it went
- U.S. Nationwide.
- How much
- 33,795 Bottles
Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bang
D-0241-2015 · Class III · reported 2014-11-12 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
- Product
- Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3
- Where it went
- Nationwide.
- How much
- 13,177 bottles
Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-362
D-0244-2015 · Class III · reported 2014-11-12 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
- Product
- Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
- Where it went
- Nationwide.
- How much
- 22,710 bottles
Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-362
D-0243-2015 · Class III · reported 2014-11-12 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
- Product
- Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
- Where it went
- Nationwide.
- How much
- 11,062 bottles
Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bang
D-0242-2015 · Class III · reported 2014-11-12 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
- Product
- Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
- Where it went
- Nationwide.
- How much
- 18,493
Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RT
D-1576-2014 · Class II · reported 2014-09-10 · Terminated
- Why it was recalled
- Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
- Product
- Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3
- Where it went
- Nationwide and Puerto Rico
Showing the 30 most recent of 42. 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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