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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98658

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 27, 2026
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Appco Pharma LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.

D-0419-2026
Recall number
D-0419-2026
Initiated
March 27, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Appco Pharma LLC
Quantity
88,008 bottles- 100's count

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP deviation

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Code information

Lot:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN.

Distribution pattern

U.S.A. Nationwide

drug · product 2 of 3

Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.

D-0420-2026
Recall number
D-0420-2026
Initiated
March 27, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Appco Pharma LLC
Quantity
58,896 bottles- 100's count

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP deviation

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Code information

Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.

Distribution pattern

U.S.A. Nationwide

drug · product 3 of 3

Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.

D-0421-2026
Recall number
D-0421-2026
Initiated
March 27, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Appco Pharma LLC
Quantity
28,157 bottles- 100's count

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP deviation

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Code information

Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. .

Distribution pattern

U.S.A. Nationwide