Dicyclomine Hydrochloride Recalled Due to Empty Capsules

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for dicyclomine hydrochloride tablets, 10 mg. The affected batch has been identified as Lot DMC125018A (expires July 2027), containing 6408 bottles.
• The recall was initiated by Aurobindo Pharma USA, Inc due to reports of empty capsules, a quality issue that is likely to cause temporary or medically reversible adverse health consequences and has a low probability of serious adverse health consequences.
• Dicyclomine hydrochloride is used to treat irritable bowel syndrome (IBS).

The FDA has issued a Class II recall for dicyclomine hydrochloride tablets, 10 mg, affecting 6408 bottles. This product is being recalled by Aurobindo Pharma USA, Inc based in East Windsor, New Jersey. The recall was initiated on July 23, 2026, and received a Class II classification on August 8, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated when the firm received reports of empty capsules. This deficiency affects Lot DMC125018A, which will expire in July 2027. Aurobindo Pharma USA sent out a public notice via letter; no press release has been issued for this recall.

Dicyclomine hydrochloride relaxes the muscles in the gastrointestinal tract to relieve symptoms of IBS. Pharmacists should identify and quarantine Lot DMC125018A, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. August 12, 2026. Accessed August 12, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221718