The Harvard Drug Group: 28 FDA recall reports
Every drug recall the FDA has published for The Harvard Drug Group. The fault, and how the agency graded it.
28Reports
1Class I
0Ongoing
2023-07-05Most recent
1 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.
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceu
D-0878-2023 · Class II · reported 2023-07-05 · Terminated
- Why it was recalled
- Packaging defect: blister packaging inadequately sealed.
- Product
- Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
- Where it went
- Nationwide in the U.S.
- How much
- 3876 cartons
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only
D-0570-2023 · Class III · reported 2023-05-17 · Terminated
- Why it was recalled
- Product mixup: one foreign tablet found in product.
- Product
- Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61
- Where it went
- USA Nationwide
- How much
- 3984 cartons
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Repub
D-0432-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- Packaging defect: observed packaging defect, blister packaging inadequately sealed.
- Product
- Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4
- Where it went
- Distributed Nationwide in the USA
- How much
- 17,586 cartons
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MA
D-0653-2022 · Class II · reported 2022-03-23 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
- Product
- hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
- Where it went
- Nationwide within USA
- How much
- 5,953 cartons
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufact
D-0649-2022 · Class II · reported 2022-03-16 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61
- Where it went
- Nationwide within the United States
- How much
- 174 cartons
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 1717
D-0289-2022 · Class II · reported 2021-12-29 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
- Where it went
- Nationwide USA
- How much
- 2,239 bottles
Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharm
D-0807-2021 · Class II · reported 2021-09-29 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC 0904-6172-61
- Where it went
- NC
- How much
- 4 Cartons of 100 count each
Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceutic
D-0806-2021 · Class II · reported 2021-09-29 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04
- Where it went
- CO, FL, MO, OH
- How much
- 1,632 cartons
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-708
D-0652-2021 · Class II · reported 2021-07-21 · Terminated
- Why it was recalled
- Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
- Product
- NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA
- Where it went
- Distributed in OH and NJ
- How much
- 504 Cartons of 50 count each; 372 Cartons of 100 count each
Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toro
D-0114-2021 · Class II · reported 2020-12-09 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: Out of specification for dissolution.
- Product
- Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
- Where it went
- Nationwide
- How much
- 841 cartons
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx onl
D-1360-2020 · Class II · reported 2020-07-08 · Terminated
- Why it was recalled
- CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61
- Where it went
- Nationwide USA
- How much
- 1,906 Cartons
Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x
D-1288-2020 · Class II · reported 2020-06-10 · Terminated
- Why it was recalled
- Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
- Product
- Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.
- Where it went
- Nationwide within the United States
- How much
- 16,443 cartons
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufac
D-1262-2020 · Class III · reported 2020-05-20 · Terminated
- Why it was recalled
- Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
- Product
- Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61
- Where it went
- AL, FL, IA, NY, OH, TX
- How much
- 678 cartons
Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured
D-1000-2020 · Class III · reported 2020-03-18 · Terminated
- Why it was recalled
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Product
- Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6802-61
- Where it went
- Nationwide
- How much
- 1 carton
Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured
D-1002-2020 · Class III · reported 2020-03-18 · Terminated
- Why it was recalled
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Product
- Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6804-61
- Where it went
- Nationwide
Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured
D-1001-2020 · Class III · reported 2020-03-18 · Terminated
- Why it was recalled
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Product
- Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6803-61
- Where it went
- Nationwide
- How much
- 115 cartons
Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured b
D-0999-2020 · Class III · reported 2020-03-18 · Terminated
- Why it was recalled
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Product
- Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61
- Where it went
- Nationwide
- How much
- 330 cartons
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Ma
D-0844-2020 · Class III · reported 2020-02-26 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: High out of specification result observed at stability studies.
- Product
- Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61
- Where it went
- U.S.A. Nationwide
- How much
- 246 Cartons
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pha
D-0013-2018 · Class II · reported 2017-10-25 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
- Product
- Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.
- Where it went
- Nationwide in the USA
- How much
- 3,935 cartons
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, D
D-1120-2017 · Class II · reported 2017-08-30 · Terminated
- Why it was recalled
- Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
- Product
- Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85
- Where it went
- Nationwide in the USA
- How much
- 7,272 bottles
Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles,
D-1119-2017 · Class II · reported 2017-08-30 · Terminated
- Why it was recalled
- Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
- Product
- Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85
- Where it went
- Nationwide in the USA
- How much
- 7,308 bottles
Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed
D-1122-2017 · Class II · reported 2017-08-30 · Terminated
- Why it was recalled
- Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
- Product
- Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47
- Where it went
- Nationwide in the USA
- How much
- 4,715 bottles
Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by:
D-1121-2017 · Class II · reported 2017-08-30 · Terminated
- Why it was recalled
- Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
- Product
- Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09
- Where it went
- Nationwide in the USA
- How much
- 26,891 bottles
Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distr
D-1123-2017 · Class II · reported 2017-08-30 · Terminated
- Why it was recalled
- Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
- Product
- Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, ?Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59
- Where it went
- Nationwide in the USA
- How much
- 32,413 bottles
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Ca
D-0692-2017 · Class III · reported 2017-05-10 · Terminated
- Why it was recalled
- Superpotent Drug; out of specification results for assay (manufacturer)
- Product
- Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
- Where it went
- Nationwide and PR
- How much
- 36,990 tablets
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratorie
D-0689-2017 · Class II · reported 2017-05-10 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61
- Where it went
- Nationwide within the US
- How much
- 914 cartons
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratorie
D-0688-2017 · Class II · reported 2017-05-10 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61
- Where it went
- Nationwide within the US
- How much
- 2,341 cartons
Class I
Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby
D-0022-2017 · Class I · reported 2016-10-19 · Terminated
- Why it was recalled
- Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
- Product
- Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85
- Where it went
- Nationwide
- How much
- 153,432 bottles
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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