Teva Recalls Amoxicillin Oral Suspension Due to Discoloration on Foil Seal
Teva Pharmaceuticals is recalling specific lots of Amoxicillin for Oral Suspension because of orange to brown discoloration found on the inner foil seal.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a cosmetic defect (discoloration) with no reported injuries or illnesses.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 109,080 bottles of Amoxicillin for Oral Suspension, USP 200 mg/5 mL. The affected products are available in 75 mL and 100 mL bottles and were distributed nationwide. The recall involves specific lot numbers with an expiration date of 08/14.
The recall is being conducted due to an orange to brown discolored Amoxicillin powder observed on the inner foil seal of the bottles. This action is an expansion of a previous recall identified as RES 65050.
Consumers who have these specific bottles should stop using them and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- AMOXICILLIN (AMOXICILLIN)
- Brand
- AMOXICILLIN
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 109,080
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 (6)
- Lot #s: a) 35426557A
- 35426558A
- Exp 08/14
- b) 35426554A
- 35426555A
- 35426556A
UPCs (9)
- 0300933107051
- 0300932264014
- 0300934161731
- 0300933109055
- 0300932267015
- 0300932268012
- 0300932263017
- 0300934160734
- 0300934155730
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · AMOXICILLIN
- ModerateAmoxicillin oral suspension recalled for temperature storage deviation
FDA (Drugs) · 2024-01-03
- HighAmoxicillin tablets recalled due to improper storage temperature exposure
FDA (Drugs) · 2024-01-03
- HighAmoxicillin capsules recalled due to temperature exposure during manufacturing
FDA (Drugs) · 2022-06-15
- LowWest-Ward Recalls Amoxicillin Suspension Due to Missing Strength Label Panel
FDA (Drugs) · 2016-11-30
- ModerateTeva Recalls Amoxicillin Oral Suspension Due to Potency Issues
FDA (Drugs) · 2016-08-31
Same manufacturer · Teva Pharmaceuticals USA, Inc.
See all →- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
- SevereOctreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance
FDA (Drugs) · 2026-05-13
- ModerateClaravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
FDA (Drugs) · 2026-04-29
- ModerateTeva clonidine 0.3 mg patches recalled over unapproved raw material use
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 40 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
Same hazard · discoloration
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateFresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
Similar recalls
- LowTeva Recalls Amoxicillin Powder Due to Discoloration on Inner Foil Seal
FDA (Drugs) · 2013-06-19
- ModerateTeva Recalls Amoxicillin Oral Suspension Due to Potency Issues
FDA (Drugs) · 2016-08-31
- ModerateTeva Recalls Amoxicillin Oral Suspension Due to Low Potency
FDA (Drugs) · 2017-02-01
- HighTeva Recalls Subpotent Amoxicillin Oral Suspension Bottles Nationwide
FDA (Drugs) · 2019-04-24
- ModerateTeva Recalls Cefdinir Oral Suspension Due to Improperly Sealed Bottles
FDA (Drugs) · 2013-04-17
- LowWest-Ward Recalls Amoxicillin Suspension Due to Missing Strength Label Panel
FDA (Drugs) · 2016-11-30