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Class II · ModerateRecall completed

Albuterol Sulfate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot number18MC-052, 18MC-055, 18MC-056, 18MC-057, 18MC-058, 18MC-060, EXP 09/2020; 18MC-061, 18MC-062, 18MC-064, 18MC-065, 18MC-066, 18MC-068, 18MC-069, 18MC-070, 18MC-071, 18MC-072, 18MC-073, 18MC-074 EXP 10/2020; 18MC-075, 18MC-076, 18MC-077, 18MC-078, 18MC-079, 18MC-080, 18MC-081, 18MC-082, 18MC-083, 18MC-084, 18MC-085 EXP 11/2020; 18MC-095, 18MC-096, 18MC-097, 18MC-098, 18MC-099 EXP 12/2020; 19MC-001, 19MC-002, 19MC-003, 19MC-004 EXP 1/2021; 19MC-005, 19MC-006, 19MC-007, 19MC-008, 19MC-009, 19MC-010, 19MC-011, 19MC-012, 19MC-013, 19MC-014, 19MC-015 EXP 2/2021; 19MC-020, 19MC-041, 19MC-042, 19MC-043, 19MC-044, 19MC-045 EXP 4/2021; 19MC-046, 19MC-047, 19MC-048, 19MC-049, 19MC-050, 19MC-051, 19MC-052 EXP 5/2021; 19MC-053, 19MC-054, 19MC-055, 19MC-056, 19MC-057, 19MC-059, 19MC-060 EXP 6/2021; 19MC-061, 19MC-062, 19MC-063, 19MC-064, 19MC-065, 19MC-066, 19MC-067, 19MC-068, 19MC-069, 19MC-070, 19MC-083, 19MC-084, 19MC-085 EXP 7/2021; 19MC-087, 19MC-088, 19MC-090, 19MC-091, 19MC-092, 19MC-093, 19MC-094, 19MC-095, 19MC-096, 19MC-097, 19MC-098, 19MC-099 EXP 8/2021; 19MC-101, 19MC-102, 19MC-103, 19MC-104, 19MC-107, 19MC-108, 19MC-109, 19MC-110, 19MC-112, 19MC-113 EXP 9/2021; 20MC-014, 20MC-015, 20MC-016, 20MC-017, 20MC-020, 20MC-021, 20MC-072 EXP 3/2022; 20MC-022, 20MC-023, 20MC-024, 20MC-029, 20MC-030, 20MC-032, 20MC-034, 20MC-035, 20MC-036, 20MC-037, 20MC-038, 20MC-039, 20MC-040, 20MC-041, 20MC-042, 20MC-043, 20MC-044 EXP 4/2022; 20MC-045, 20MC-046, 20MC-047, 20MC-048, 20MC-049, 20MC-050, 20MC-051, 20MC-052, 20MC-053, 20MC-054, 20MC-061, 20MC-062, 20MC-063, 20MC-064, 20MC-065, 20MC-066, 20MC-067, 20MC-068 EXP 5/2022; 20MC-069, 20MC-070, 20MC-078, 20MC-079, 20MC-080, 20MC-081, 20MC-083, 20MC-084 EXP 6/2022
Where it was soldNationwide in the U.S.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Defective Delivery System: Sustained trend of failure to dispense complaints.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCatalent Pharma Solutions, 160 N Pharma Drive, Morrisville, NC 27560, Distributed by: Perrigo, Allegan, MI 49010
Brand nameALBUTEROL SULFATE
Generic nameALBUTEROL SULFATE
Active ingredient(s)ALBUTEROL SULFATE
Distributed by / forPerrigo, Allegan, MI 49010
NDC45802-088-01
Show the full FDA record
Full product labelAlbuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Pharma Drive, Morrisville, NC 27560, Distributed by: Perrigo, Allegan, MI 49010 NDC 45802-088-01
Recalling firmPerrigo Company PLC
DistributionNationwide in the U.S.
Quantity7,775,813 metered dose inhalers
Recall initiated2020-09-16
Report date2020-09-30
Recall completed2023-05-22
Recall numberD-1594-2020
ClassificationClass II
FDA statusTerminated
Origin on fileAllegan MI United States

Related

Albuterol recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.