Dicyclomine Hydrochloride Capsules Recall Issued by Aurobindo
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Aurobindo Pharma USA Inc. is recalling 6,408 bottles of Dicyclomine Hydrochloride Capsules, USP, 10mg due to shortfill and reports of empty capsules.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 18, 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, fda, Drugs.
What Happened
Aurobindo Pharma USA Inc. initiated a voluntary Class II recall of Dicyclomine Hydrochloride Capsules after reports of shortfill and empty capsules.
Which Products Are Affected
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000-count bottles, Rx only, NDC 59651-719-99. Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Batch # DMC125018A, Exp Date: 07/2027. 6,408 bottles distributed nationwide.
What You Should Do
Consumers with affected product should contact the recalling firm regarding the recall.
Why This Matters
This ongoing recall affects prescription medication distributed across the United States, with potential implications for patients relying on the product for its intended use.
Source
FDA recall number D-0733-2026. Data from FDA enforcement report.
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 (851 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 18, 2026.
Frequently Asked Questions
Common questions about this FDA recall.