Perrigo recalls EQUALINE aller-ease fexofenadine hydrochloride tablets due to failed impurity tests. Affected lots from 2021-2022 may contain harmful substances. Consumers should contact Perrigo for details.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Perrigo is recalling EQUALINE aller-ease fexofenadine hydrochloride tablets (180mg, 24-hour) that failed stability testing for impurity A. This could mean harmful substances are present in some batches, though the recall doesn't specify immediate health risks.
The tablets failed stability testing for impurity A, which could mean harmful substances are present. This is a quality issue that might not cause immediate harm but could pose a risk if the impurities affect the medication's safety.
People who bought EQUALINE aller-ease fexofenadine hydrochloride tablets (180mg, 24-hour) from the listed lots between 2021 and 2022 are affected. Those with allergies to fexofenadine or similar medications may be at higher risk.
Check for the NDC numbers: 41163-571-22 (15-count bottle) or 41163-571-01 (70-tablet bottle). The lots listed (0HE2530, 0KE2980, 0FR0461) were made in the Czech Republic and distributed by UNFI.
Identify your product by checking the NDC numbers (41163-571-22 or 41163-571-01) and lot numbers (0HE2530, 0KE2980, 0FR0461).
The recall states the tablets failed stability testing for impurity A, but it does not specify immediate health risks or injuries. The official notice does not say this is dangerous.
Check for the NDC numbers: 41163-571-22 (15-count bottle) or 41163-571-01 (70-tablet bottle) and lot numbers (0HE2530, 0KE2980, 0FR0461).
The recall does not specify a remedy, so the official notice does not say what to do next.
We’ve drafted a message you can send Perrigo to request your refund or repair — edit it as you like.
Subject: Recall D-0328-2022 — Perrigo Perrigo Hello, I own a Perrigo that is covered by recall D-0328-2022 from Perrigo. 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.