Sun Pharmaceutical recalls 360mg Diltiazem Hydrochloride Extended-Release Capsules due to failed impurity and dissolution testing. Rx-only bottles with specific lot numbers and expiration dates are affected.
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Sun Pharmaceutical is recalling 360mg Diltiazem Hydrochloride Extended-Release Capsules that failed stability and dissolution tests. This means the capsules may contain unsafe impurities that could cause health risks if taken.
The capsules failed impurity testing and dissolution testing at FDA labs, meaning they may contain unsafe levels of deacetyl diltiazem hydrochloride. This could lead to health issues if the medication is taken as prescribed.
Prescription drug users who have the specific lot numbers listed in the recall. People taking this medication for heart conditions are most at risk.
Check the bottle for the lot numbers: HAC3120A, HAC3121A (expiring 04/2023), HAC4460A (expiring 10/2023), HAD0365A (expiring 12/2023), or HAD1452A (expiring 02/2024). The product is a prescription-only 360mg capsule.
Look for the lot numbers HAC3120A, HAC3121A, HAC4460A, HAD0365A, or HAD1452A on the bottle.
The capsules failed impurity and dissolution testing at FDA laboratories, meaning they may contain unsafe levels of deacetyl diltiazem hydrochloride.
Check the lot numbers on the bottle. If you have any of the listed lot numbers, contact your doctor or pharmacist for guidance.
The recall indicates the medication may contain unsafe impurities, so it is not safe to take as recalled. Consult your healthcare provider.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0262-2023 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0262-2023 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
