Lanreotide Acetate Injection Recall by Cipla USA
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Cipla USA, Inc. is recalling 54,583 syringes of Lanreotide Injection due to a lack of assurance of sterility from deficiencies in visual inspection procedures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 22, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
Cipla USA, Inc. is recalling Lanreotide Injection because of a lack of assurance of sterility, stemming from deficiencies in the visual inspection procedure at the contract manufacturing site.
Which Products Are Affected
The affected product is Lanreotide Injection, 120 mg/0.5 mL, with NDC 69097-870-67. A total of 54,583 syringes are involved, distributed nationwide in the USA. The specific lots and expiry dates include: 4401666IR1 (Exp 8/31/2027), 4401703IR1 (Exp 9/30/2027), 4401703IR2 (Exp 9/30/2027), 4401704IR1 (Exp 9/30/2027), 4401705IR1 (Exp 9/30/2027), 4401706IR1 (Exp 9/30/2027), 4401720IR1 (Exp 9/30/2027), 4401721IR1 (Exp 9/30/2027), 4401733IR1 (Exp 9/30/2027), 4401770IR1 (Exp 9/30/2027), 4401777IR1 (Exp 9/30/2027), 4401788IR1 (Exp 10/31/2027), 4401804IR1 (Exp 10/31/2027), 4401805IR1 (Exp 10/31/2027), 4401824IR1 (Exp 10/31/2027), 4401860IR1 (Exp 10/31/2027), 4500019IR1 (Exp 11/30/2027), 4500035IR1 (Exp 11/30/2027), 4500036IR1 (Exp 11/30/2027), 4500078IR1 (Exp 11/30/2027), 4500079IR1 (Exp 11/30/2027), 4500102IR1 (Exp 12/31/2027), 4500119IR1 (Exp 12/31/2027), 4500120IR1 (Exp 12/31/2027), 4500121IR1 (Exp 12/31/2027), 4500268IR1 (Exp 1/31/2028), 4500269IR1 (Exp 1/31/2028), 4500272IR1 (Exp 1/31/2028), 4500314IR2 (Exp 1/31/2028), 4500314RIR (Exp 1/31/2028), 4500315IR1 (Exp 2/28/2028), 4500352IR1 (Exp 2/28/2028), 4500353IR1 (Exp 2/28/2028), 4500354IR1 (Exp 2/28/2028), 4500355IR1 (Exp 2/28/2028), 4500408IR1 (Exp 2/28/2028), 4500409IR1 (Exp 3/31/2028), 4500410IR1 (Exp 3/31/2028), 4500480IR1 (Exp 3/31/2028), 4500481IR1 (Exp 3/31/2028), 4500545IR1 (Exp 3/31/2028), 4500546IR1 (Exp 3/31/2028), 4500588IR1 (Exp 4/30/2028), 4500589IR1 (Exp 4/30/2028), 4500635IR1 (Exp 4/30/2028), 4500636IR1 (Exp 4/30/2028), 4500687IR1 (Exp 4/30/2028), 4500688IR1 (Exp 4/30/2028), 4500758IR1 (Exp 4/30/2028), 4500759IR1 (Exp 5/31/2028), 4500788IR1 (Exp 5/31/2028), 4500789IR1 (Exp 5/31/2028), 4500819IR1 (Exp 5/31/2028), 4500846IR1 (Exp 5/31/2028), 4500849IR1 (Exp 6/30/2028), 4500850IR1 (Exp 7/31/2028), 4500907IR1 (Exp 7/31/2028), 4501108IR1 (Exp 7/31/2028), 4501109IR1 (Exp 7/31/2028), 4501110IR1 (Exp 7/31/2028), 4501111IR1 (Exp 7/31/2028), 4501166IR1 (Exp 7/31/2028), 4501386IR1 (Exp 8/31/2028), and 4501387IR1 (Exp 8/31/2028). The recall number is D-0422-2026.
What You Should Do
Consumers should contact Cipla USA, Inc. at their address, 10 Independence Blvd, Warren, NJ 07059, for instructions on returning the affected products, as the recall was initiated via letter.
Why This Matters
This recall involves a prescription drug with potential sterility issues, which could pose health risks if compromised, highlighting the importance of manufacturing quality in pharmaceuticals.
Source
FDA recall notice: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts (attribution to FDA, recall event ID 98575)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.