Teva Recalls Albuterol Sulfate Syrup Due to Foreign Particles
Teva North America is recalling 8,052 bottles of Albuterol Sulfate Syrup because black particles were found in the product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, an FDA Class II recall involving a significant hazard (foreign substance in a medication) corresponds to a severity score of 4 (Severe), as it is not explicitly Class I but involves a tangible physical defect in a drug product.
Plain-English summary
Teva North America is recalling 8,052 bottles of Albuterol Sulfate Syrup, 2 mg/5 mL, 473 mL bottles. The product is prescription-only and was manufactured in Canada by Contract Pharmaceuticals Limited for Teva Pharmaceuticals USA. The specific lot number is 95113, with an expiration date of 01/2017.
The recall was initiated due to the presence of a foreign substance, described as black particles. The source text identifies these particles generically as cellulose-based bundles of brown fibrous material. The FDA has classified this recall as Class II.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific NDC (0093-0661-16) and lot number. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16
- Manufacturer
- Teva North America
- Category
- Drug — Prescription Liquid
- Affected units
- 8,052
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 95113
- exp 01/2017
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Teva North America
See all →- ModerateTeva Recalls Claravis Isotretinoin Capsules Due to Impurity Failures
FDA (Drugs) · 2016-10-12
- ModerateTeva Recalls Ondansetron Injection Vials Due to Manufacturing Deviations
FDA (Drugs) · 2016-09-14
- ModerateTeva Recalls Eptifibatide Injection Vials Due to Manufacturing Deviations
FDA (Drugs) · 2016-09-14
- ModerateTeva Recalls Argatroban Injection Due to Manufacturing Deviations
FDA (Drugs) · 2016-09-14
- SevereTeva Recalls Linezolid Injection Due to Manufacturing Deviations
FDA (Drugs) · 2016-09-14
Same hazard · foreign substance
See all →- ModerateHeritage Pharmaceuticals Recalls Clindamycin Palmitate Hydrochloride Due to Foreign Particles
FDA (Drugs) · 2026-08-19
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- ModerateCorlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
FDA (Drugs) · 2026-07-01
- LowHydroxyzine Hydrochloride Oral Solution recalled for foreign substance
FDA (Drugs) · 2026-07-01
- ModerateCorlanor ivabradine tablets recalled for presence of foreign substance
FDA (Drugs) · 2026-07-01
Similar recalls
- LowTeva Recalls Albuterol Sulfate Inhalation Solution Due to Impurities
FDA (Drugs) · 2017-08-09
- SevereTeva Recalls Adrucil Fluorouracil Injection Due to Particulate Matter
FDA (Drugs) · 2015-07-15
- SevereTeva Recalls Dextroamphetamine Sulfate Tablets Due to Impurity Test Failures
FDA (Drugs) · 2014-07-02
- SevereTeva Recalls Amikacin Sulfate Injection Due to Glass Particulate Matter
FDA (Drugs) · 2016-06-01
- ModerateTeva Recalls Seasonale Tablets Due to Impurity Detection
FDA (Drugs) · 2013-06-05
- SevereTeva Recalls Alprostadil Injection Due to Impurity Testing Failures
FDA (Drugs) · 2018-11-21