The Recall Desk
ModerateFDA (Drugs)·D-0340-2022·Announced 2022-01-12

H.E.B Allergy Relief Fexofenadine Tablets Recalled for Failed Impurity Specifications

H.E.B Allergy Relief fexofenadine hydrochloride tablets (180mg) are being recalled nationwide due to out-of-specification results for impurity A found during stability testing. The affected product is available in 15, 30, and 45 count bottles.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a labeling/specification issue rather than an active safety hazard with reported illness or injury. The failure relates to impurity specifications found during testing with no reported patient harm documented in the source text.

Plain-English summary

Perrigo Company PLC is recalling H.E.B Allergy Relief, Fexofenadine Hydrochloride 180mg tablets (24HR) due to failed impurities and degradation specifications. During stability testing, an out-of-specification result was obtained for impurity A.

The recall affects three package sizes: 15 count bottles (NDC 37808-571-22), 30 count bottles (NDC 37808-571-39), and 45 count bottles (NDC 37808-571-95). A total of 13,920 containers have been distributed nationwide in the USA.

Affected lot numbers and expiration dates are: 0HE2530 (Exp 12/31/2021), 0JE2407 (Exp 2/28/2022), 1BR0462 (Exp 10/31/2022), 0FR0460 (Exp 2/28/2022), and 0LR0363 (Exp 6/30/2022).

Consumers who have purchased this product should consult with a pharmacist or healthcare provider about whether they should stop using it and obtain a replacement.

The recalled product

Product
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Ma
Manufacturer
Perrigo Company PLC
Category
Drug — Antihistamine / Over-the-Counter
Hazard
  • impurity-specification
  • degradation-specification

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Lot a) 0HE2530
  • Exp 12/31/2021
  • 0JE2407
  • Exp 2/28/2022: b) 1BR0462
  • Exp 10/31/2022 c) 0FR0460
  • Exp 2/28/2022: 0LR0363
  • Exp 6/30/2022

Distribution

Distributed nationwide across the United States.

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