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Fexofenadine Hydrochloride
Fexofenadine Hydrochloride recalls: 11 FDA reports
Recalls involving Fexofenadine Hydrochloride. What was wrong with each batch, and how the FDA graded the risk.
11Reports
0Class I
0Ongoing
2024-01-31Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC
D-0273-2024 · Class II · reported 2024-01-31 · Completed
- Why it was recalled
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Product
- Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.
- Where it went
- Nationwide in the USA
- How much
- 54,504 bottles
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39)
D-0912-2023 · Class II · reported 2023-07-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007.
- Where it went
- Nationwide within the USA
- How much
- 44,280 cartons
allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39);
D-0909-2023 · Class II · reported 2023-07-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811.
- Where it went
- Nationwide within the USA
- How much
- 32,904 cartons
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0),
D-0906-2023 · Class II · reported 2023-07-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
- Where it went
- Nationwide within the USA
- How much
- 59,688 cartons
Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC
D-0907-2023 · Class II · reported 2023-07-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78
- Where it went
- Nationwide within the USA
- How much
- 15,504 cartons
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distributi
D-0902-2023 · Class II · reported 2023-07-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, Salisbury, NC 28147. NDC 72476-847-22
- Where it went
- Nationwide within the USA
- How much
- 3,240 cartons
Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-coun
D-0908-2023 · Class II · reported 2023-07-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.
- Where it went
- Nationwide within the USA
- How much
- 32,376 cartons
Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b
D-0900-2023 · Class II · reported 2023-07-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count cartons (NDC 72288-847-47 and 72288-847-37), Distributed By: Amazon.com Services LLC., 410 Terry Avenue N., Seattle, WA 98109.
- Where it went
- Nationwide within the USA
- How much
- 11,904 cartons
Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's
D-0901-2023 · Class II · reported 2023-07-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Club, 25 Research Drive, Westborough, MA 01581. NDC 68391-847-47
- Where it went
- Nationwide within the USA
- How much
- 23,868 cartons
Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Ea
D-0905-2023 · Class II · reported 2023-07-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 49010 USA. NDC 63981-847-48
- Where it went
- Nationwide within the USA
- How much
- 360,184
aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchange
D-0904-2023 · Class II · reported 2023-07-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Perrigo Company, Allegan, MI USA 49010. NDC 55301-847-39
- Where it went
- Nationwide within the USA
- How much
- 1,920 cartons
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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