Torrent Pharma Inc

Torrent Pharma Inc: 84 FDA recall reports

Every drug recall the FDA has published for Torrent Pharma Inc. The fault, and how the agency graded it.

84Reports
1Class I
33Ongoing
2025-06-11Most recent
1 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.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt 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

ClassReports
Class II82
Class I1
Class III1

By year reported

YearReports
20131
201813
201963
20202
20211
20222
20252
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.

Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD.,

D-0456-2025  ·  Class II  ·  reported 2025-06-11  ·  Completed

Why it was recalled
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Product
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)
Where it went
U.S. Nationwide.
How much
972 Cartons

Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indra

D-0455-2025  ·  Class II  ·  reported 2025-06-11  ·  Completed

Why it was recalled
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Product
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30
Where it went
U.S. Nationwide.
How much
3672 Bottles

Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torr

D-0852-2022  ·  Class II  ·  reported 2022-05-11  ·  Terminated

Why it was recalled
CGMP deviations: tablets cracking
Product
Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.
Where it went
Nationwide in the U.S.A
How much
24,888 bottles

Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceutical

D-0365-2022  ·  Class II  ·  reported 2022-01-19  ·  Terminated

Why it was recalled
Failed Dissolution Specifications
Product
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.
Where it went
Nationwide USA
How much
15,336 Bottles

Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by:

D-0285-2022  ·  Class III  ·  reported 2021-12-22  ·  Terminated

Why it was recalled
Superpotent; Hydrochlorothiazide
Product
Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30
Where it went
Nationwide USA
How much
27,312 Bottles
Class I

Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking

D-0166-2021  ·  Class I  ·  reported 2020-12-09  ·  Terminated

Why it was recalled
Failed Dissolution Specifications
Product
Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01
Where it went
Nationwide USA and Puerto Rico
How much
2496 Bottles

Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceu

D-1317-2020  ·  Class II  ·  reported 2020-06-10  ·  Terminated

Why it was recalled
Failed Dissolution Specifications
Product
Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05
Where it went
USA Nationwide and Puerto Rico
How much
6228 Bottles

Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured

D-0124-2020  ·  Class II  ·  reported 2019-10-09  ·  Ongoing

Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Product
Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
Where it went
Nationwide USA and Puerto Rico
How much
8,688 bottles

Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufacture

D-0123-2020  ·  Class II  ·  reported 2019-10-09  ·  Ongoing

Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Product
Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90
Where it went
Nationwide USA and Puerto Rico
How much
17,088 bottles

Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc.

D-0121-2020  ·  Class II  ·  reported 2019-10-09  ·  Ongoing

Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Product
Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
Where it went
Nationwide USA and Puerto Rico
How much
8,688 bottles

Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent P

D-0122-2020  ·  Class II  ·  reported 2019-10-09  ·  Ongoing

Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Product
Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
Where it went
Nationwide USA and Puerto Rico
How much
39,432 bottles

Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc.,

D-1862-2019  ·  Class II  ·  reported 2019-09-25  ·  Terminated

Why it was recalled
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Product
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.
Where it went
Nationwide in the USA and Puerto Rico
How much
2472 bottles

Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536

D-1371-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536-1850-97, Distributed by Rugby Laboratories, Livonia MI 48152.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
62,748 bottles

Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, A

D-1367-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10mL)), 4 Fl. oz. bottle, NDC: 0536-2310-97, Distributed by Rugby Laboratories, Livonia MI 48152.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
66,060 bottles

Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured B

D-1375-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Pharm Inc., Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
264 bottles

Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin

D-1359-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
53,520 bottles

Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118

D-1369-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
176,580 bottles

Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-5

D-1373-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Manufactured By Bio-Pharm, Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
153.540 bottles

Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC:

D-1378-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
82,872 bottles

Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free,

D-1346-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, Inc., Levittown PA 19057, Assured.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
58,272 bottles

Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz

D-1368-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
249,744 bottles

Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful c

D-1352-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains diphenhydramine hydrochloride, USP 12.5 mg, a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-1228-00, b) One Pint (473 mL) bottle, NDC: 0904-5174-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
655,104 bottles

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz.

D-1383-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
11,112 bottles

RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuti

D-1382-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
52,368 bottles

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz.

D-1384-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
7,728 bottles

Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-

D-1380-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
1,126,404 bottles

Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per ca

D-1379-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
177,408 bottles

Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma

D-1374-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
5,681 bottles

Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0

D-1349-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-0061-00, b) One Pint ( 473 mL) bottle, NDC: 0904-0061-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
984,888 bottles

Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc.,

D-1362-2019  ·  Class II  ·  reported 2019-06-19  ·  Terminated

Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.
Where it went
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
How much
14,016 bottles

Showing the 30 most recent of 84. 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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