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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97573

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

Open FDA event record

Event summary

Timeline bucket
September 12, 2025
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
JB Chemicals and Pharmaceuticals Ltd

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

2 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 2

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.

D-0032-2026
Recall number
D-0032-2026
Initiated
September 12, 2025
Classification
Class III
Status
Ongoing
Quantity
9936 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tablet/Capsules Imprinted with Wrong ID

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Tablet/Capsules Imprinted with Wrong ID

Code information

Lot # PY925014A; Exp. 1/31/2028

Distribution pattern

U.S. Nationwide

drug · product 2 of 2

Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50

D-0033-2026
Recall number
D-0033-2026
Initiated
September 12, 2025
Classification
Class III
Status
Ongoing
Quantity
13,440 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tablet/Capsules Imprinted with Wrong ID

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Tablet/Capsules Imprinted with Wrong ID

Code information

Lot # PY925014, PY925013, Exp. 1/31/2028

Distribution pattern

U.S. Nationwide