CLASS II Drug recall · Reported 30 Sep 2020 · FDA Enforcement Report
Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation recalled
Perrigo is recalling Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, distributed nationwide in the US. The recall was initiated on 16 Sep 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1594-2020
- FDA event ID
- 86429
- Recalling firm
- Perrigo, Allegan, MI
- Brand
- Albuterol Sulfate
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Sep 2020
- FDA classified
- 23 Sep 2020
- Reported
- 30 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Inhalers & Asthma Medication
Timeline
| 16 Sep 2020 | Recall initiated by company | |
| 23 Sep 2020 | Classified by FDA | +7 days |
| 30 Sep 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Sustained trend of failure to dispense complaints.
Product as listed by the FDA
Albuterol 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
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Defective Delivery System: Sustained trend of failure to dispense complaints.
Which lots are affected?
18MC-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 was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Albuterol recalls
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg recalled | Nephron SC | Other | Nationwide |
| Drug | CLASS III | Albuterol Sulfate, Inhalation Aerosol, 90 mcg recalled by Cipla USAAlbuterol Sulfate | Cipla USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Airsupra (albuterol and budesonide) inhalation aerosol recalledAirsupra | AsttraZeneca Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Albuterol Sulfate HFA Inhalation Aerosol recalled by Cardinal HealthcareAlbuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Albuterol Sulfate IN 90MCG per actuation, 200 Metered Inhalations recalledAlbuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |