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.
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
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Code information
Lot #: KA00411, KA00412, KA00460, Exp 11/2021
Distribution pattern
U.S.A. Nationwide
drug · product 2 of 3
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-528-34
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Code information
Lot #: KA00413, KA00414, KA00461, Exp 11/2021
Distribution pattern
U.S.A. Nationwide
drug · product 3 of 3
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34
