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Taro Pharmaceuticals U.S.A., Inc.
Taro Pharmaceuticals U.S.A., Inc.: 36 FDA recall reports
Every drug recall the FDA has published for Taro Pharmaceuticals U.S.A., Inc.. The fault, and how the agency graded it.
36Reports
3Class I
0Ongoing
2024-08-21Most recent
3 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.
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., B
D-0633-2024 · Class III · reported 2024-08-21 · Completed
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
- Product
- Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
- Where it went
- Product was distributed to one distributor
- How much
- 96 vials
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pha
D-0727-2022 · Class III · reported 2022-04-06 · Terminated
- Why it was recalled
- Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
- Product
- Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1
- Where it went
- Product was distributed to one retail consignee in NY.
- How much
- 768 tubes
Class I
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., H
D-0375-2022 · Class I · reported 2022-01-19 · Terminated
- Why it was recalled
- Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
- Product
- Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3
- Where it went
- Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
- How much
- 96 tubes
Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay
D-0246-2021 · Class II · reported 2021-02-10 · Terminated
- Why it was recalled
- CGMP deviations.
- Product
- Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1
- Where it went
- Nationwide
- How much
- 44,256 bottles
Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The K
D-0154-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Product
- Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45202 Made in Canada. NDC 30142-305-01
- Where it went
- Distributed Nationwide in the USA and Canada
- How much
- 133,452 0.5 oz tubes
TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distri
D-0158-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Product
- TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 49569 2
- Where it went
- Distributed Nationwide in the USA and Canada
- How much
- N/A
RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by:
D-0156-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Product
- RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1
- Where it went
- Distributed Nationwide in the USA and Canada
- How much
- 34,920 0.5 oz tubes
Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The
D-0155-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Product
- Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01
- Where it went
- Distributed Nationwide in the USA and Canada
- How much
- 45,396 units
CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by:
D-0150-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Product
- CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03
- Where it went
- Distributed Nationwide in the USA and Canada
- How much
- 64,692 1 oz tubes
Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro
D-0159-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Product
- Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10531. Made in Canada. UPC 3 51672 20022 0
- Where it went
- Distributed Nationwide in the USA and Canada
- How much
- 40,896 1 oz tube
Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed by: Valu Merchandisers
D-0157-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Product
- Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed by: Valu Merchandisers, CO . 5000 Kansas Ave. Kansas City, KS 66106 Made in Canada. UPC 0-70038-20355-1
- Where it went
- Distributed Nationwide in the USA and Canada
- How much
- 11,088 1 oz tubes
Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Phar
D-0153-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Product
- Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T1C1 Distributed by Kaiser Foundation Hospitals Livemore, CA 94551-9756. Made in Canada. NDC 0179-8014-30
- Where it went
- Distributed Nationwide in the USA and Canada
- How much
- 30,816 1 oz tubes
Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035
D-0151-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Product
- Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g), NDC 49035-812-27. Distributed by: Walmart Inc., Bentonville, AR 72716.
- Where it went
- Distributed Nationwide in the USA and Canada
- How much
- 481,896 tubes
H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride
D-0152-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Product
- H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride & Care for H-E-B San Antonio, TX 78204 Made in Canada NDC 37808-305-01
- Where it went
- Distributed Nationwide in the USA and Canada
- How much
- N/A
Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx
D-1496-2020 · Class III · reported 2020-08-19 · Terminated
- Why it was recalled
- Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
- Product
- Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.
- Where it went
- Nationwide in the U.S.
- How much
- 7632 tubes
Class I
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals In
D-0863-2020 · Class I · reported 2020-03-04 · Terminated
- Why it was recalled
- Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
- Product
- Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1
- Where it went
- Distributed Nationwide in the USA.
- How much
- 29,172 8 Fl Oz bottles
Class I
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Hai
D-0833-2020 · Class I · reported 2020-02-19 · Terminated
- Why it was recalled
- Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
- Product
- Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.
- Where it went
- Nationwide in the U.S. and Puerto Rico.
Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals
D-0299-2020 · Class II · reported 2019-11-06 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Product
- Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9
- Where it went
- U.S.A. Nationwide
- How much
- 639,325 bottles
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(24
D-0301-2020 · Class II · reported 2019-11-06 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Product
- Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1
- Where it went
- U.S.A. Nationwide
- How much
- 5,190 bottles
Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceutical
D-0298-2020 · Class II · reported 2019-11-06 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Product
- Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8
- Where it went
- U.S.A. Nationwide
- How much
- 138,886 bottles
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(12
D-0302-2020 · Class II · reported 2019-11-06 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Product
- Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04
- Where it went
- U.S.A. Nationwide
- How much
- 5,280 bottles
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (12
D-0300-2020 · Class II · reported 2019-11-06 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Product
- Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8
- Where it went
- U.S.A. Nationwide
- How much
- 182,986 bottles
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 F
D-0277-2019 · Class II · reported 2018-11-21 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- Product
- children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.
- Where it went
- Nationwide in the USA
- How much
- 8328 bottles
children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Fre
D-0278-2019 · Class II · reported 2018-11-21 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- Product
- children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.
- Where it went
- Nationwide in the USA
Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye
D-0276-2019 · Class II · reported 2018-11-21 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- Product
- Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.
- Where it went
- Nationwide in the USA
- How much
- 12,432 bottles
Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa
D-0249-2018 · Class III · reported 2018-02-07 · Terminated
- Why it was recalled
- Failed Content Uniformity Specifications
- Product
- Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3
- Where it went
- Nationwide
- How much
- 27,792 tubes
Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L
D-0146-2018 · Class III · reported 2017-11-01 · Terminated
- Why it was recalled
- Cross contamination with other products: traces of Dapsone were found in the finished product.
- Product
- Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1
- Where it went
- Nationwide
- How much
- 16,944 tubes
Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals
D-0790-2017 · Class III · reported 2017-05-24 · Terminated
- Why it was recalled
- Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
- Product
- Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3
- Where it went
- U.S. Nationwide
- How much
- 7,776 tubes
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide,
D-0676-2017 · Class II · reported 2017-04-26 · Terminated
- Why it was recalled
- Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
- Product
- Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532
- Where it went
- Nationwide and Puerto Rico
- How much
- 278,304 tubes
Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.
D-0134-2017 · Class III · reported 2016-11-16 · Terminated
- Why it was recalled
- Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
- Product
- Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC
- Where it went
- Nationwide
- How much
- 17,100 kits
Showing the 30 most recent of 36. 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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