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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Drugs.
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 →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (2,855 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 22, 2026.
Frequently Asked Questions
Common questions about this FDA recall.