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Cipla USA, Inc.

FDA Regulatory Profile

Cipla USA, Inc. has 24 FDA recalls (1 Class I), 0 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest recall
D-0014-2027 · Class II · Sep 18, 2026

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls24 (1 Class I)Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Cipla Limited
Same company group		30352Oct 31, 2025 (D-0197-2026)
Invagen Pharmaceuticals
Same company group		110210Nov 17, 2023 (D-0220-2024)
Cipla
Same company group		110110Sep 29, 2022 (D-1550-2022)

Recent Recalls

NumberClassProductDate
D-0014-2027Class IIFosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1…Sep 18, 2026
D-0676-2026Class IICinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd…Jun 29, 2026
D-0675-2026Class IICinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd…Jun 29, 2026
D-0661-2026Class IICinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd…Jun 29, 2026
D-0449-2026Class IICinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla…Mar 16, 2026
D-0451-2026Class IICinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla…Mar 16, 2026
D-0450-2026Class IICinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla…Mar 16, 2026
D-0422-2026Class IILanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single…Mar 13, 2026
D-0423-2026Class IILanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only…Mar 13, 2026
D-0381-2026Class IIINilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd…Feb 18, 2026
D-0382-2026Class IIINilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA…Feb 18, 2026
D-0290-2026Class IILanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection…Jan 2, 2026
D-0291-2026Class IIIDiclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd…Dec 22, 2025
D-0224-2026Class IICinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla…Nov 14, 2025
D-0226-2026Class IICinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla…Nov 14, 2025
D-0225-2026Class IICinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla…Nov 14, 2025
D-0217-2026Class IILanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only…Oct 24, 2025
D-0218-2026Class IILanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only…Oct 24, 2025
D-0593-2025Class IIIAlbuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g…Jul 24, 2025
D-0541-2025Class IIBudesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX…Jun 30, 2025

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.