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Recall totals

All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.

37,066

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,786

Class I recallsReasonable probability of serious health consequences

24,313

Class II recallsTemporary or medically reversible health consequences

2,876

Class III recallsNot likely to cause adverse health consequences

Quick insights

A snapshot of the most notable patterns across all recorded FDA and USDA recalls.

Most recalled product100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap. 53 recalls

Most common hazardLack of Assurance of Sterility 2,072 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/whole-foods-market-issues-allergy-alert-undeclared-egg-cabricharme-cheesePublished September 11, 2026

Most affected stateHawaii 200 recalls mention this state

State: PR ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 12, 2026 ET

Summary (Year to date)

1,527 recalls have been announced year to date.
Aug 2026 was 24% lower than the previous complete period (Jul 2026: 240).
The highest complete period was Jun 2026 (297).
Sep 2026 is incomplete and not included in the figures above.

Complete data
Incomplete

Recalls by class

Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

FDA Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-238-01, UPC 3 16729 23801 4

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-237-01, UPC 3 16729 23701 7

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-236-01, UPC 3 16729 23601 0

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-235-01, UPC 3 16729 23501 3

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-234-01, UPC 3 16729 23401 6

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, UPC 3 16729 23301 9

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-011-15, UPC 3 16729 01115 0

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-010-17, UPC 3 16729 01017 7

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-009-15, UPC 3 16729 00915 7.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottle NDC 16729-008-16, UPC 3 16729 00816 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-468-15, UPC 3 16729 46815 2.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Packet NDC 16729-521-63, UPC 3 16729 52163 5; Carton NDC 16729-521-11, UPC 3 16729 52111 6.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 16729-370-16, UPC 3 16729 37016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-493-45, UPC 3 16729 49345 1.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

View recall →

FDA Recall Terminated Historical recordClass II

Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count bottle NDC 16729-005-17, UPC 3 16729 00517 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

View recall →

Data last updated: September 12, 2026 ET

Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions. Read the full medical disclaimer.