Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister ...

FDA Drug Recall #D-0938-2023 — Class I — June 27, 2023

Recall Summary

Recall Number D-0938-2023
Classification Class I — Serious risk
Date Initiated June 27, 2023
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cipla USA, Inc.
Location Warren, NJ
Product Type Drugs
Quantity 278,538 canisters

Product Description

Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60

Reason for Recall

Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

Distribution Pattern

Nationwide in the US

Lot / Code Information

Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023

Other Recalls from Cipla USA, Inc.

Recall # Classification Product Date
D-0381-2026 Class III Nilotinib Capsules, 150 mg per capsule, package... Feb 18, 2026
D-0382-2026 Class III Nilotinib Capsules, 200 mg per capsule, package... Feb 18, 2026
D-0290-2026 Class II Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per... Jan 2, 2026
D-0291-2026 Class III Diclofenac Sodium Topical Gel, 1%, NET WT 100 g... Dec 22, 2025
D-0226-2026 Class II Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tab... Nov 14, 2025

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.