Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufa...
FDA Drug Recall #D-0593-2025 — Class III — July 24, 2025
Recall Summary
| Recall Number | D-0593-2025 |
| Classification | Class III — Low risk |
| Date Initiated | July 24, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cipla USA, Inc. |
| Location | Warren, NJ |
| Product Type | Drugs |
| Quantity | 20352 packs (1x 200 MD) |
Product Description
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
Reason for Recall
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Distribution Pattern
U.S. Nationwide.
Lot / Code Information
Lot#: 4IB0519, Exp. 04/30/2026
Other Recalls from Cipla USA, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0450-2026 | Class II | Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tab... | Mar 16, 2026 |
| D-0449-2026 | Class II | Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tab... | Mar 16, 2026 |
| D-0451-2026 | Class II | Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tab... | Mar 16, 2026 |
| D-0422-2026 | Class II | Lanreotide Injection, 120 mg*/0.5 mL, Box conta... | Mar 13, 2026 |
| D-0423-2026 | Class II | Lanreotide Injection, 120 mg/0.5 mL, Box contai... | Mar 13, 2026 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.